The Recall Desk

Archive

August 2017 recalls

1,004 recalls were announced in August 2017.

What the numbers show

Critical
75
Severe
160
High
480
Moderate
267
Low
22

Of the 1,004 recalls this month scored against our rubric, 7% are Critical, 16% are Severe.

Which agencies issued them

501–600 of 1004

  • ModerateFDA (Devices)·Z-2906-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

    Valorem Surgical LLC is recalling Pallas M/MAXIMIS Poly Screws because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 7.5 x 50mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2969-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Rod Bender for Quality Issues

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Rod Benders because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Rod Bender. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2842-2017·2017-08-16

    FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes and hypodermic needles nationwide because of insufficient documentation to support product sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 5 CC L/L 22 G X 1.0, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2831-2017·2017-08-16

    FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation

    International Medsurg Connection is recalling 54.2 million piston syringes and hypodermic needles because documentation supporting sterility claims is insufficient.

    Product
    Piston Syringe and Hypodermic Needle, 3 CC L/L 21 G X 1.5, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2806-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection is recalling 54.2 million hypodermic needles because documentation supporting their sterility claims is insufficient.

    Product
    Hypodermic Needle, 18 G X 1 in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2893-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 50mm MIS Rods

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 50mm MIS Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 50mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2917-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS MIS Pedicle Screws because they are not consistent with FDA Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MIS Screw 6.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3015-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Guide Wires for Quality System Issues

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Guide Wires because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Guide Wire. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2926-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS MIS Pedicle Screws because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MIS Screw 6.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2862-2017·2017-08-16

    FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes because the company lacks sufficient documentation to support the products' sterility claims.

    Product
    Piston Syringe, 60 CC L/S, 50 per box, 8 boxes/case, 400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2943-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Spinal Fixation Rods

    Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 50mm spinal fixation rods due to quality system non-compliance. The devices are distributed nationwide in the US.

    Product
    PALLAS M/MAXIMIS 50mm Curved and precontoured Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2970-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Compressor for Quality System Non-Compliance

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Compressors because the devices are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Compressor. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2954-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Spinal Fixation Rods

    Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 250mm Straight Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 250mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3009-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS S. Spinal Fixation Probes

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS S. probes used in spinal fixation systems because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS S. Probe. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2939-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 30 mm Curved Rods

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 30 mm Curved Rods due to non-compliance with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 30 mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2930-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS MIS Pedicle Screws because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MIS Screw 6.5 x 55mm and 6.5 x 5.5 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2876-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Crosslink Spinal Fixation Devices

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Crosslink devices because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Crosslink 50-70mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2920-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS pedicle screws because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 7.5 x 45mm screw and 7.5 x 4.5 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2994-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Nut Drivers for Quality System Non-Compliance

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Nut Drivers because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Nut Driver 4.5 Star and Final Driver 4.0. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical sp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2843-2017·2017-08-16

    FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 units of piston syringes and hypodermic needles because of insufficient documentation to support sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 5 CC L/L 22 G X 1.5, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2891-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 35mm MIS Rods for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 35mm MIS Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 35mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2824-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling 54,204,100 hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.

    Product
    Hypodermic Needle, 30 G X 1.0 in DISP HYPO, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3013-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Persuader Spinal Fixation Instruments

    Valorem Surgical is recalling 262 Pallas M/MAXIMIS Persuader instruments because they do not meet FDA quality system requirements.

    Product
    PALLAS M/MAXIMIS Persuader. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2934-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 5.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2834-2017·2017-08-16

    FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 units of piston syringes and hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.5, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2840-2017·2017-08-16

    FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 units of piston syringes and hypodermic needles because the company lacks sufficient documentation to support product sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 5 CC L/L 21 G X 1.0, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2950-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 50mm Straight Rods

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 50mm Straight Rods because the devices are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 50mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2938-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 6.5 x 50mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2993-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Anti Torque Devices for Quality Issues

    Valorem Surgical is recalling 262 Pallas M/MAXIMIS Anti Torque Devices because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Anti Torque Device. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2974-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Inside Bender Spinal Fixation Devices

    Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS Inside Bender devices due to quality system non-compliance.

    Product
    PALLAS M/MAXIMIS Inside Bender (L) and (R). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2841-2017·2017-08-16

    FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation

    International Medsurg Connection is recalling 54.2 million piston syringes and hypodermic needles because the company lacks documentation to support the products' sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 5 CC L/L 21 G X 1.5, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2924-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

    Valorem Surgical LLC is recalling Pallas M/MAXIMIS MIS Pedicle Screws because the devices are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MIS Screw 5.5 x 50mm and 5.5 x 5.0 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2850-2017·2017-08-16

    International Medsurg Piston Syringes Recalled for Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes because the company lacks sufficient documentation to support the products' sterility claims.

    Product
    Piston Syringe, 1 CC L/S, 100 per box, 40 boxes/case, 4,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of dise
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3358-2017·2017-08-16

    ISABEL Octopus in Marinera Sauce Recalled for Mislabeling as Squid

    ISABEL North America is recalling Octopus in marinera sauce because the label states Octopus but the actual content is Squid.

    Product
    ISABEL, Octopus in marinera sauce, Pulpo en salsa marinera, Net wt - Peso Neto 4 oz(115g)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2857-2017·2017-08-16

    FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation

    International Medsurg Connection is recalling 54,204,100 piston syringes nationwide because documentation supporting their sterility claims is insufficient.

    Product
    Piston Syringe, 20 CC L/L, 100 per box, 9 boxes/case, 900/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of diseas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2847-2017·2017-08-16

    FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 units of piston syringes and hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 10 CC L/L 21 G X 1.5, 100 per box, 10 boxes/case, 1,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigatio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2815-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling hypodermic needles because the company lacks sufficient documentation to support its product sterility claims.

    Product
    Hypodermic Needle, 22 G X 1.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2805-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling 16-gauge hypodermic needles because the company lacks sufficient documentation to support the product's sterility claims.

    Product
    Hypodermic Needle, 16G X 1.5in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2989-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Extension Guide Bushes for Quality Issues

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Extension Guide Bushes because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Extension Guide Bush. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2945-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 70mm Curved Rods

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 70mm Curved Rods due to non-compliance with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 70mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3355-2017·2017-08-16

    Duy Drugs Recalls Viva ben Femenine Supplement for CGMP Violations

    Duy Drugs Inc. is recalling 1,800 bottles of Viva ben Femenine Supplement because the product failed to meet current good manufacturing practices (CGMPs) for identity, purity, and composition.

    Product
    Viva ben Femenine Supplement, Dietary Supplement 30 Softgels
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1060-2017·2017-08-16

    AtHome Medical Recalls Liquid Oxygen Due to GMP Deviations

    AtHome Medical, Inc. is recalling 80 lbs of Oxygen Refrigerated Liquid USP due to a lack of standard operating procedures for testing out-of-specification products.

    Product
    Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morris Plains, NJ 07950,973-538-0485.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2937-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

    Valorem Surgical LLC is recalling Pallas M/MAXIMIS Poly Screws because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 6.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2957-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 40mm Rods for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 40mm Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 40mm Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2982-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS MIS Tapper 5.5mm Spinal Fixation Devices

    Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS MIS Tapper 5.5mm because the devices are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MIS Tapper 5.5mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2848-2017·2017-08-16

    FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes and hypodermic needles nationwide because the company lacks sufficient documentation to support the products' sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 10 CC L/L 22 G X 1.0, 100 per box, 10 boxes/case, 1,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigatio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2833-2017·2017-08-16

    FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 units of piston syringes and hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.25, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigatio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2979-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Dilator A Spinal Fixation Devices

    Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS Dilator A due to quality system non-compliance. The devices are used for spinal fixation.

    Product
    PALLAS M/MAXIMIS Dilator A. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2839-2017·2017-08-16

    FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 units of piston syringes and hypodermic needles nationwide because the company lacks sufficient documentation to support product sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 5 CC L/L 20 G X 1.5, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3016-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Rod Pusher B Instruments

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Rod Pusher B instruments due to quality system non-compliance. The devices are part of a spinal fixation system.

    Product
    PALLAS M/MAXIMIS Rod Pusher B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2882-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 30mm Spinal Fixation Rods

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 30mm rods due to quality system non-compliance. The devices are distributed nationwide in the US.

    Product
    PALLAS M/MAXIMIS 30mm Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2889-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 80mm MIS Rods

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 80mm MIS Rods due to inconsistencies with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 80mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2911-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Pedicle Screws because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Polyaxial and MIS Screw, 5.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2852-2017·2017-08-16

    FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes because the company lacks sufficient documentation to support the products' sterility claims.

    Product
    Piston Syringe, 3 CC L/S, 100 per box, 30 boxes/case, 3,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of dise
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2827-2017·2017-08-16

    FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes and hypodermic needles because the company lacks sufficient documentation to support product sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 1 CC TB 28 G X 0.5, 100 per box, 30 boxes/case, 3,000/case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2818-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.

    Product
    Hypodermic Needle, 25 G X 1.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2936-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

    Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they do not meet FDA quality system requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 6.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2972-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Marking Pins for Quality Issues

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Marking Pins because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Marking Pin (Smooth). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2992-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Poly Screw Drivers for Quality Issues

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Poly Screw Drivers because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MISS/MIS Poly Screw Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2961-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Awl for Quality System Non-Compliance

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Awls because the devices are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Awl. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3359-2017·2017-08-16

    ISABEL Octopus in Garlic Sauce Recalled for Mislabeling as Squid

    ISABEL North America is recalling Octopus in Garlic Sauce because the label states Octopus but the actual content is Squid.

    Product
    ISABEL, Octopus in garlic sauce, Pulpo al ajillo, Net wt - Peso Neto 4 oz(115g)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2814-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection is recalling hypodermic needles because documentation supporting sterility claims is insufficient. The recall covers 54,204,100 units distributed nationwide.

    Product
    Hypodermic Needle, 22 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3007-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Head Holders for Quality Issues

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Head Holders because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Head Holder. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2844-2017·2017-08-16

    FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes and hypodermic needles nationwide because of insufficient documentation to support product sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 10 CC L/L 20 G X 1.0, 100 per box, 10 boxes/case, 1,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigatio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2809-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling hypodermic needles because the company lacks sufficient documentation to support the product's sterility claims.

    Product
    Hypodermic Needle, 19 G X 1.5 in BD YALE DISP RG, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatme
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2904-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Poly Screws for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 7.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2838-201·2017-08-16

    FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes and hypodermic needles because the company lacks sufficient documentation to support product sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 5 CC L/L 20 G X 1.0, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2877-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Crosslink Spinal Fixation Devices

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Small Crosslink devices because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Small Crosslink. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2858-2017·2017-08-16

    FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes because the company lacks sufficient documentation to support product sterility claims.

    Product
    Piston Syringe, 20 CC L/S, 100 per box, 9 boxes/case, 900/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of diseas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2984-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Spinal Fixation Extensions

    Valorem Surgical is recalling 262 Pallas M/MAXIMIS Open Extension (Small) devices because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Open Extension (Small). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3002-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Torque Handles for Quality System Issues

    Valorem Surgical is recalling 262 Pallas M/MAXIMIS Torque Handles because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Torque Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3017-2017·2017-08-16

    Elekta Recalls iGUIDE Software 2.2 Due to Incorrect PEC Values

    Elekta, Inc. is recalling iGUIDE Software 2.2 because it contains incorrect PEC values. The software is used for patient positioning in radiotherapy environments.

    Product
    iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-3000-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Rod Checker and T-Bar Devices

    Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS Rod Checker and T-Bar devices due to quality system non-compliance.

    Product
    PALLAS M/MAXIMIS Rod Checker and T-Bar. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2914-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

    Valorem Surgical is recalling Pallas M/MAXIMIS MIS Pedicle Screws because they are not consistent with FDA Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MIS Screw 6.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2819-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection is recalling 54,204,100 hypodermic needles because the company lacks sufficient documentation to support the product's sterility claims.

    Product
    Hypodermic Needle, 25 G X 5/8 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2991-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Compass Spinal Fixation Devices

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Compass devices because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Compass. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2828-2017·2017-08-16

    FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes and hypodermic needles nationwide because of insufficient documentation to support sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 3 CC L/L 20 G X 1.0, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2886-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 50mm MIS Rods for Quality Issues

    Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 50mm MIS Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 50mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2949-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 45mm Straight Rods

    Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 45mm Straight Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 45mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2942-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 45mm Curved Rods

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 45mm Curved Rods due to quality system non-compliance. The devices are part of a spinal fixation system.

    Product
    PALLAS M/MAXIMIS 45mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2896-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 120mm MIS Rods for Quality Issues

    Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 120mm MIS Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 120mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2996-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Rod Checkers for Quality System Defects

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Rod Checkers because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Rod Checker. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2835-201·2017-08-16

    FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 units of piston syringes and hypodermic needles because documentation supporting sterility claims is insufficient.

    Product
    Piston Syringe and Hypodermic Needle, 3 CC L/L 23 G X 1.0, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2935-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Poly Screws for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because the devices are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 6.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2976-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screw Fixation System

    Valorem Surgical is recalling 262 units of the Pallas M/MAXIMIS Reduction B. part of the MAXIMIS Pedicle Screw Spinal Fixation System because the devices are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Reduction B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2892-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 45mm MIS Rods for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 45mm MIS Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 45mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2854-2017·2017-08-16

    International Medsurg Piston Syringes Recalled for Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes because the company lacks sufficient documentation to support the products' sterility claims.

    Product
    Piston Syringe, 5 CC L/S, 100 per box, 20 boxes/case, 2,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of diseas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2816-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection is recalling 54.2 million hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.

    Product
    Hypodermic Needle, 23 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2932-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with FDA Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 5.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2958-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 350 Straight Rods for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 350 Straight Rods because the devices are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 350 Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2959-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 400mm Straight Rods

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 400mm Straight Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 400mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2899-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Poly Spinal Fixation Screws

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 5.5 x 50mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2985-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screw Extensions for Quality Issues

    Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS Open Extensions because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Open Extension (Large). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2817-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection is recalling hypodermic needles because the company lacks documentation to support the products' sterility claims.

    Product
    Hypodermic Needle, 25 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2988-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Extension Drivers for Quality System Issues

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Extension Drivers because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Extension Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2900-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with FDA Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 6.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2908-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with FDA Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 5.5 x 30mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2879-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Curved Rods for Quality System Non-Compliance

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 5.5 x 05mm Curved Rods because the devices are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 5.5 x 05mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2811-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.

    Product
    Hypodermic Needle, 20 G X 1.5 in BD YALE DISP RG, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatme
    Category
    Medical Device
    Distribution
    Distributed nationwide

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