The Recall Desk

Archive

December 2013 recalls

1,402 recalls were announced in December 2013.

What the numbers show

Critical
351
Severe
605
High
191
Moderate
225
Low
30

Of the 1,402 recalls this month scored against our rubric, 25% are Critical, 43% are Severe.

Which agencies issued them

1301–1400 of 1402

  • SevereFDA (Food)·F-0370-2014·2013-12-04

    Plum Kids Blueberry Blitz Fruit and Veggie Mashups Recalled for Contamination

    Plum Inc is recalling Blueberry Blitz Fruit & Veggie Mashups due to a manufacturing defect that led to post-process contamination.

    Product
    Plum Kids Blueberry Blitz Fruit & Veggie Mashups, 12.69 oz. box. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0417-2014·2013-12-04

    DePuy Orthopaedics Recalls HP M.B.T. Keel Punch Knee Instruments

    DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.

    Product
    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0413-2014·2013-12-04

    DePuy Orthopaedics Recalls HP M.B.T. Keel Punch Knee Instruments

    DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.

    Product
    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0382-2014·2013-12-04

    Nexgen Pharma Recalls Woman's Once Daily Vitamin Tablets Due to Chloramphenicol Contamination

    Nexgen Pharma is recalling one lot of Woman's Once Daily vitamin tablets because they were contaminated with the antibiotic Chloramphenicol.

    Product
    PCC, Rebecca's Natural Food, Sprouts Famous Market, Ritzman Pharmacy, Earth Fare, Hartig Drug, Viroqua Food, Ramona Fitness Center, Independent Choice (Health Trail Natural Foods-The Crunchy Grocer), Jimbo's, Outpost Natural Foods BRANDS- Woman's Once Daily Tablets - A dietary…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0385-2014·2013-12-04

    Roche Recalls ACCU-CHEK Aviva Combo Blood Glucose Meters

    Roche is recalling 6,595 ACCU-CHEK Aviva Combo Blood Glucose Meters due to a software issue that may cause incorrect insulin bolus advice.

    Product
    ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0390-2014·2013-12-04

    Synthes Recalls 3.7mm and 5.0mm Dynamic Locking Screws Due to Breakage

    Synthes USA HQ, Inc. is recalling 3.7mm and 5.0mm Dynamic Locking Screws because they may break at the distal tip during removal.

    Product
    3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0424-2014·2013-12-04

    B. Braun addEASE Binary Connector Recalled for Possible Solution Leakage

    B. Braun Medical is recalling addEASE Binary Connectors because a misaligned needle may cause solution to leak from the PAB bag.

    Product
    20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0378-2014·2013-12-04

    Plum Strawberry Barley Pouches Recalled for Post-Process Contamination

    Plum Inc is recalling Strawberry Barley pouches due to a manufacturing defect that led to post-process contamination. The product was distributed nationwide and internationally.

    Product
    Plum, Strawberry Barley Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0140-2014·2013-12-04

    Siemens RAD Fluoro Uro System Recalled for Radiation Malfunction

    Siemens is recalling 59 RAD Fluoro Uro systems because a software malfunction can cause radiation to continue longer than required, resulting in overexposed images.

    Product
    Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G Image intensified Fluoroscopic X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0356-2014·2013-12-04

    Plum Organics Baby Food Recalled for Manufacturing Defect

    Plum Inc is recalling Plum Organics Plum, Berry & Barley Organic Baby Food due to a manufacturing defect leading to post-process contamination.

    Product
    Plum Organics Plum, Berry & Barley Organic Baby Food; 3.5 oz. Pouch; Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0395-2014·2013-12-04

    Synthes Polyaxial Screw Body Recalled for Potential Post-Operative Loosening

    Synthes USA is recalling 757 units of Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Bodies due to reported complaints of post-operative locking cap loosening.

    Product
    Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0425-2014·2013-12-04

    B. Braun Recalls addEASE Binary Connectors Due to Solution Leakage

    B. Braun Medical is recalling 4,000 addEASE Binary Connectors because a misaligned needle may cause solution to leak from the bag stopper.

    Product
    13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC1300 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0364-2014·2013-12-04

    Plum Organics Baby Food Recalled for Manufacturing Defect

    Plum Inc is recalling Sweet Potato, Corn & Apple Organic Baby Food due to a manufacturing defect that led to post-process contamination.

    Product
    Plum Organics Sweet Potato, Corn & Apple Organic Baby Food- 4 oz. Pouch Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0390-2014·2013-12-04

    Las Trojes Sesame Seed Brittle Recalled for Undeclared Soy Lecithin

    Las Trojes is recalling sesame seed brittle because it may contain undeclared soy lecithin, a common allergen.

    Product
    Sesame Seed Brittle ("Pepitoria De Ajonjoli"), in cellophane packages, Net Wt. 2 oz (57g), UPC 6 61444 00006 5.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0416-2014·2013-12-04

    DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk

    DePuy Orthopaedics is recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.

    Product
    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0389-2014·2013-12-04

    Mindray Recalls V Series Patient Monitors Due to Power Pin Issue

    Mindray is recalling V Series Patient Monitors because power pins may lose tension, causing the screen to go blank or shut down.

    Product
    Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the V Series include the monitoring…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0359-2014·2013-12-04

    Plum Organics Baby Food Recalled for Manufacturing Defect and Contamination

    Plum Inc is recalling Cherry & Sweet Corn Organic Baby Food due to a manufacturing defect that led to post-process contamination.

    Product
    Plum Organics Cherry & Sweet Corn Organic Baby Food, 4 oz. pouch. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0354-2014·2013-12-04

    Plum Organics Baby Food Recalled for Post-Process Contamination

    Plum Inc is recalling Plum Organics Apple Raisin & Quinona Organic Baby Food due to a manufacturing defect that led to post-process contamination.

    Product
    Plum Organics Apple Raisin & Quinona Organic Baby Food; 3.5 oz. Pouch; Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0353-2014·2013-12-04

    Plum Organics Baby Food Recalled for Post-Process Contamination

    Plum Inc is recalling Sweet Potato, Mango & Millet Organic Baby Food due to a manufacturing defect that led to post-process contamination.

    Product
    Plum Organics Sweet Potato, Mango & Millet Organic Baby Food; 3.5 oz. Pouch; Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0369-2014·2013-12-04

    Plum Kids Beetbox Berry Fruit and Veggie Mashups Recalled for Contamination

    Plum Inc is recalling specific lots of Plum Kids Beetbox Berry Fruit and Veggie Mashups due to a manufacturing defect that led to post-process contamination.

    Product
    Plum Kids Beetbox Berry Fruit and Veggie Mashups, 12.69 oz. box. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0426-2014·2013-12-04

    Custom Ultrasonics Endoscope Washer/Disinfector Recalled for Incomplete Validation

    Custom Ultrasonics is recalling 118 System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector units because they were not fully validated prior to distribution.

    Product
    Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0406-2014·2013-12-04

    Synthes 2.4 mm LC-DCP Plate Recalled Due to Foreign Object

    Synthes (USA) Products LLC is recalling 13 units of 2.4 mm LC-DCP Plates because a screw was found in a package labeled for the plate.

    Product
    Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14039·2013-12-04

    Manhattan Toy Quixel Baby Rattles Recalled for Choking Hazard

    Manhattan Group is recalling Quixel baby rattles because the arches can break, creating small parts that pose a choking hazard to young children.

    Product
    Manhattan Toy® Quixel™ baby rattles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14040·2013-12-04

    Wearever Girl's Hooded Jacket Sets Recalled for Strangulation Hazard

    David's Place is recalling Wearever Girl's hooded jacket and pant sets because the hood drawstrings pose a strangulation hazard to young children.

    Product
    Girl's long sleeve hooded jacket and pant sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0414-2014·2013-12-04

    DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk

    DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.

    Product
    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14037·2013-12-04

    K2 Revo Kick Kickboards Recalled for Handle Detachment Hazard

    K2 Sports is recalling K2 Revo Kick kickboards/scooters because the front assembly can break, causing the handle to detach and posing a fall hazard to riders.

    Product
    K2 Revo Kick kickboards/scooters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0375-2014·2013-12-04

    Plum Organics Baby Food Recalled for Post-Process Contamination

    Plum Inc is recalling Kale, Apple & Greek Yogurt baby food pouches due to a manufacturing defect causing post-process contamination.

    Product
    Plum Organics Kale, Apple & Greek Yogurt Organics Baby Food- 3.5 oz. Pouch Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0350-2014·2013-12-04

    MRM Recalls Gluten Free 60 vcaps Due to Chloramphenicol Contamination

    Metabolic Response Modifier is recalling Gluten Free 60 vcaps because the product may contain trace amounts of the antibiotic chloramphenicol.

    Product
    Gluten Free 60 vcaps, sku#609492310194. 12 units per shipping carton/case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0411-2014·2013-12-04

    Biomet Recalls Shortened Plug Driver Due to Instrument Tip Shearing

    Biomet is recalling two units of a Shortened Plug Driver after a complaint reported the instrument tip sheared off during a surgical removal case.

    Product
    Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0391-2014·2013-12-04

    Las Trojes Recalls Coconut Brittle for Undeclared Soy Lecithin

    Las Trojes is recalling specific lots of Coconut Brittle because they may contain undeclared soy lecithin, a common allergen.

    Product
    Coconut Brittle ("Pepitoria De Coco"), in cellophane packages, Net Wt. 2 oz (57g), UPC 6 61444 00013 3.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0388-2014·2013-12-04

    Synthes Tensioning Device Recalled Due to Potential Mechanical Failure

    Synthes USA HQ, Inc. is recalling 369 Tensioning Devices because the reaction fork may come loose, preventing the device from applying tension or releasing the wire.

    Product
    Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0418-2014·2013-12-04

    DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk

    DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.

    Product
    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0419-2014·2013-12-04

    DePuy Recalls Knee Instruments Due to Potential Tab Fracture

    DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs may fracture and remain in patients.

    Product
    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0377-2014·2013-12-04

    Plum Inc Recalls Parsnip, Blueberry & Buckwheat Pouches for Contamination

    Plum Inc is recalling Parsnip, Blueberry & Buckwheat pouches due to a manufacturing defect that led to post-process contamination.

    Product
    Parsnip, Blueberry & Buckwheat Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·13V608000·2013-12-04

    Triumph Recalls 2013 Trophy SE Motorcycles Due to Center Stand Defect

    Triumph is recalling 416 model year 2013 Trophy SE motorcycles because the left-hand center stand mount may fracture, potentially causing the bike to fall over while parked.

    Product
    TRIUMPH — TRIUMPH TROPHY SE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0405-2014·2013-12-04

    Synthes Implant Holder Recalled Due to Breakage During Orthopedic Surgery

    Synthes USA HQ, Inc. is recalling 548 Synfix (TM)-LR Implant Holders because they may break at the interface between the implant and the holder.

    Product
    Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0391-2014·2013-12-04

    Synthes Matrix Coronal Bender Recall Due to Tip Breakage

    Synthes USA is recalling 209 Matrix 5.5mm Coronal Benders because tips broke during use. The devices are used for spinal stabilization.

    Product
    Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5 Matrix Rods in the coronal plane, and is intended for stabilization of the thoracic, lumbar, sacral, and/or iliac spine…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0412-2014·2013-12-04

    DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk

    DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.

    Product
    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0393-2014·2013-12-04

    Las Trojes Peanut Brittle Recalled for Undeclared Soy Lecithin

    Las Trojes is recalling peanut brittle products because they may contain undeclared soy lecithin, a potential allergen.

    Product
    Peanut Brittle ("Pepitoria De Cacahuate"), in cellophane packages, Net Wt. 2 oz (57g), UPC 6 61444 00012 6.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0374-2014·2013-12-04

    Siemens Fluoroscopic X-Ray Systems Recalled for Radiation Malfunction

    Siemens is recalling specific fluoroscopic x-ray systems due to a software defect that may cause radiation to continue longer than required, resulting in overexposed images.

    Product
    (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0361-2014·2013-12-04

    Plum Organics Baby Food Recalled for Post-Process Contamination Risk

    Plum Inc is recalling specific lots of Plum Organics Raspberry, Spinach & Greek Yogurt Organic Baby Food due to a manufacturing defect that could lead to post-process contamination.

    Product
    Plum Organics Raspberry, Spinach & Greek Yogurt Organic Baby Food, 4 oz. pouch. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT.…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0420-2014·2013-12-04

    DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk

    DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.

    Product
    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0363-2014·2013-12-04

    Plum Organics Baby Food Recalled for Manufacturing Defect

    Plum Inc is recalling Spinach, Peas & Pear Organic Baby Food due to a manufacturing defect that led to post-process contamination.

    Product
    Plum Organics Spinach, Peas & Pear Organic Baby Food, 4 oz. pouch.. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0381-2014·2013-12-04

    Biomet Recalls Oversized Security Blades for Carpal Tunnel Surgery

    Biomet, Inc. is recalling 1,130 Security Blades for carpal tunnel surgery because they were manufactured oversized and may be difficult to advance through the mating clip.

    Product
    REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device, Single Use Only. Designed to release the transverse carpal ligament.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0396-2014·2013-12-04

    Synthes Titanium Spinal Locking Caps Recalled for Post-Operative Loosening

    Synthes USA is recalling 745 Titanium Minimally Invasive Reduction Screw System Locking Caps due to a risk of post-operative loosening if the construct is mis-aligned during final tightening.

    Product
    Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0408-2014·2013-12-04

    Synthes Slipped Capital Femoral Epiphysis System Recalled for Drill Bit Breakage

    Synthes USA is recalling 166 units of the Slipped Capital Femoral Epiphysis System because guide wires may stick and drill bits may break during surgery.

    Product
    Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck fractures, intercondylar femur fractures and sacroiliac joint disruptions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0389-2014·2013-12-04

    Las Trojes Mixed Seed Brittle Recalled for Undeclared Soy Lecithin

    Las Trojes is recalling Mixed Seed Brittle because it may contain undeclared soy lecithin. The product was distributed in California.

    Product
    Mixed Seed Brittle ("Pepitoria Mixed"), in cellophane packages, Net Wt. 2oz (57g), UPC 6 61444 00017 1.
    Category
    Food
    Distribution
    1 state
  • HighCPSC·14038·2013-12-04

    SRAM Recalls Bicycle Derailleurs Due to Fall Hazard

    SRAM is recalling specific RED WiFLi rear derailleurs because a pivot pin can loosen, causing the derailleur to jam and posing a fall hazard.

    Product
    Bicycle chain derailleurs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0422-2014·2013-12-04

    DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk

    DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.

    Product
    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0357-2014·2013-12-04

    Plum Organics Yogurt Mish Mash Recalled for Contamination

    Plum Inc is recalling Plum Organics Tots Purple Roots and Fruits Yogurt Mish Mash due to a manufacturing defect that led to post-process contamination.

    Product
    Plum Organics Tots Purple Roots and Fruits Yogurt Mish Mash; 3.17 oz. Pouch; Also 12.69 oz. box. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0392-2014·2013-12-04

    Las Trojes Pumpkin Seed Brittle Recalled for Undeclared Soy Lecithin

    Las Trojes is recalling specific lots of Pumpkin Seed Brittle because the product may contain undeclared soy lecithin, a common allergen.

    Product
    Pumpkin Seed Brittle ("Pepitoria"), in cellophane packages, Net Wt. 2 oz (57g), UPC 6 61444 0000 5 8.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0380-2014·2013-12-04

    Plum Inc Recalls Kale, Apple & Greekstyle Yogurt Pouches

    Plum Inc is recalling Kale, Apple & Greekstyle Yogurt pouches due to a manufacturing defect that led to post-process contamination.

    Product
    Kale, Apple & Greekstyle Yogurt Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0401-2014·2013-12-04

    Kraft and Polly-O String Cheese Recalled for Potential Spoilage

    Kraft Foods Group is recalling specific varieties of Kraft and Polly-O String Cheese and String Cheese Twist products because they may spoil before their expiration dates, causing discoloration.

    Product
    Low-Moisture Part-Skim Mozzarella String Cheese, sold under Kraft brand or Polly-O brand and packaged with either 12, 16, 24, or 48 pieces of mozzarella cheese individually wrapped in plastic and sold in a plastic bag with a net weight respectively of 12 oz. (340g), 16 oz. (1…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0404-2014·2013-12-04

    Kraft and Polly-O String Cheese Recalled for Potential Spoilage

    Kraft Foods Group is recalling certain Kraft and Polly-O String Cheese products that may spoil before their expiration dates, causing discoloration.

    Product
    Low-Moisture Part-Skim Mozzarella String Cheese With Jalapeno Peppers, sold under Kraft brand or Polly-O brand and packaged with 12 pieces of mozzarella cheese with jalapeno peppers individually wrapped in plastic and sold in a plastic bag with a net weight of 10 oz. (283g).
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0410-2014·2013-12-04

    Synthes Recalls Vertebroplasty Needle Kits Due to Expiration Date Inconsistencies

    Synthes USA is recalling 40 Vertebroplasty Needle Kits because of inconsistent expiration dates on the packaging.

    Product
    Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0366-2014·2013-12-04

    Plum Organics Baby Food Recalled for Manufacturing Defect

    Plum Inc. is recalling Plum Organics Pumpkin & Banana Organic Baby Food due to a manufacturing defect that led to post-process contamination.

    Product
    Plum Organics Pumpkin & Banana Organic Baby Food, 3.5 oz. pouch.. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0392-2014·2013-12-04

    Baxter Recalls VIAL-MATE Adaptors Due to Incomplete Foil Seal

    Baxter Healthcare is recalling 38,400 units of VIAL-MATE Adaptors because an incomplete foil seal may compromise sterility.

    Product
    Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA The VIAL-MATE is reconstitution device labeled for use with 20 mm drug vials and 50mL, 100mL, and 250mL Single Pack Mini Bags.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-019-2014·2013-12-04

    Cetylite Recalls Cetacaine Topical Anesthetic Due to Low Tetracaine Levels

    Cetylite Industries is recalling Cetacaine Topical Anesthetic Liquid because the tetracaine ingredient is below specification limits at the 21-month stability test point.

    Product
    CETACAINE ANESTHETIC — CETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0399-2014·2013-12-04

    Medtronic Recalls Strata II Shunt Kits Due to Label Discrepancies

    Medtronic Neurosurgery is recalling Strata II Shunt Assembly Kits and other CSF shunts because of label discrepancies. The recall affects 5 units distributed worldwide.

    Product
    Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata II Shunt Assemblies are designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart of the peritoneal cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0405-2014·2013-12-04

    Kraft and Polly-O String Cheese Recalled for Potential Spoilage

    Kraft Foods Group is recalling specific varieties of Kraft and Polly-O String Cheese that may spoil before their expiration dates, causing discoloration.

    Product
    Low-Moisture Part-Skim Mozzarella String Cheese With Cracked Pepper, sold under Kraft brand or Polly-O brand and packaged with 12 pieces of mozzarella cheese with cracked pepper individually wrapped in plastic and sold in a plastic bag with a net weight of 10 oz. (283g).
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0403-2014·2013-12-04

    Kraft and Polly-O String Cheese Recalled for Potential Spoilage

    Kraft Foods Group is recalling specific varieties of Kraft and Polly-O String Cheese that may spoil before their expiration dates, causing discoloration.

    Product
    Low-Moisture Part-Skim Mozzarella String Cheese With Tomato and Italian Style Seasonings, sold under Kraft brand or Polly-O brand and packaged with 12 pieces of mozzarella cheese with tomato and Italian style seasoning individually wrapped in plastic and sold in a plastic bag…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0401-2014·2013-12-04

    Synthes 4.5mm Condylar Plate Recalled for Restricted Sales Release

    Synthes USA is recalling a specific lot of 4.5mm condylar plates that were inadvertently released to a sales consultant restricted for sale.

    Product
    Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar, intra-articular and extra articular condylar fractures…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0368-2014·2013-12-04

    Plum Organics Apple & Carrot Baby Food Recalled for Contamination

    Plum Inc is recalling Apple & Carrot Organic Baby Food due to a manufacturing defect that led to post-process contamination.

    Product
    Plum Organics Apple & Carrot Organic Baby Food, 4.0 oz. pouch.. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0409-2014·2013-12-04

    Synthes 4.5 mm LCP Curved Condylar Plate Recalled for Mislabeling

    Synthes USA HQ, Inc. is recalling 13 units of the 4.5 mm LCP Curved Condylar Plate because straight plates are etched with the curved plate's part number.

    Product
    Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0378-2014·2013-12-04

    Mizuho Sugita Titanium Aneurysm Clips Recalled for Discoloration

    Mizuho America is recalling 35 units of Sugita Titanium Standard Aneurysm Clip II, Temporary Mini Type No 58 due to discoloration in specific lots.

    Product
    Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0381-2014·2013-12-04

    Houston Nutraceuticals Recalls TriEnza Bulk Powder for Chloramphenicol

    Houston Nutraceuticals is recalling TriEnza bulk powder because it may contain chloramphenicol above permitted limits. The product was distributed internationally to Brazil.

    Product
    TriEnza bulk powder distributed in a 5 kilogram polyethylene bag.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0230-2014·2013-12-04

    Cenk Disczyme A Dietary Supplement Recalled for Chloramphenicol Contamination

    FoodScience Corporation is recalling Cenk Disczyme A dietary supplements because they may contain trace amounts of the antibiotic chloramphenicol.

    Product
    Cenk Disczyme A Dietary Supplement for Complete Digestive Support, 180 count capsule Distributed by Cenk Integrated Health & Spine Services, 107 Gamma Drive Ste 100, Pittsburgh, PA 15328
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0406-2014·2013-12-04

    Kraft and Polly-O String Cheese Recalled for Potential Spoilage

    Kraft Foods Group is recalling specific varieties of Kraft and Polly-O String Cheese and String Cheese Twist products because they may spoil before their 'Best When Used By' dates, causing discoloration.

    Product
    Low-Moisture Part-Skim Mozzarella String Cheese With Barbecue Seasoning, sold under Kraft brand or Polly-O brand and packaged with 12 pieces of mozzarella cheese with barbecue seasoning individually wrapped in plastic and sold in a plastic bag with a net weight of 9 oz. (255g).
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0377-2014·2013-12-04

    Mizuho Sugita Titanium Aneurysm Clips Recalled for Discoloration

    Mizuho America is recalling 32 units of Sugita Titanium Standard Aneurysm Clip II due to discoloration. The devices are intended for single use in cerebral aneurysms.

    Product
    Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0403-2014·2013-12-04

    Advanced Sterilization Products Recalls STERRAD NX Sterilization Systems

    Advanced Sterilization Products is recalling STERRAD NX and STERRAD 100NX sterilization systems because bronchoscopes may contain unlisted polyurethane material in the suction channel.

    Product
    STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0349-2014·2013-12-04

    4Life Recalls Digestive Enzymes Due to Chloramphenicol Contamination

    4Life Research is voluntarily recalling specific lots of Digestive Enzymes dietary supplements because they contain trace amounts of the antibiotic chloramphenicol.

    Product
    Digestive Enzymes, Digestion, 4Life, Dietary Supplement, 90 Capsules, A Product of 4Life Manufactured by BioMedical Research Laboratories, LLC, Sandy, UT, Item #23017.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0404-2014·2013-12-04

    Synthes 14.5 mm Outer Protection Sleeve Recalled for Incorrect Size

    Synthes (USA) Products LLC is recalling 55 units of 14.5 mm Outer Protection Sleeves that were incorrectly packaged as 12.0 mm units.

    Product
    Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabilize fractures of the proximal and distal tibia and the tibia shaft, open and closed tibia shaft…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0380-2014·2013-12-04

    Synthes 2.4 and 2.7 mm Locking Screws Recalled for Mislabeling

    Synthes USA is recalling 98 units of 2.4 and 2.7 mm Locking Screws because 2.7 mm screws were incorrectly labeled as 2.4 mm.

    Product
    2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0407-2014·2013-12-04

    Kraft and Polly-O String Cheese Recalled for Potential Spoilage

    Kraft Foods Group is recalling specific varieties of Kraft and Polly-O String Cheese and String Cheese Twist products that may spoil before their expiration dates, causing discoloration.

    Product
    Low-Moisture Part-Skim Mozzarella String Cheese With Jalapeno Peppers, sold under Kraft brand and packaged with 24 pieces of mozzarella cheese with jalapeno peppers individually wrapped in plastic and sold in a cardstock display box bag with a net weight of 24 oz. (1 lb. 8 oz.)…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0228-2014·2013-12-04

    LWL Enzyme Life Dietary Supplement Recalled for Chloramphenicol

    FoodScience Corporation is recalling LWL Enzyme Life dietary supplements because they may contain trace amounts of the antibiotic chloramphenicol.

    Product
    Life Worth Living Nutriceuticals LWL Enzyme Life A Dietary Supplement for Complete Digestive Support, Distributed by Life Worth Living Nutriceuticals, 6488 Currin Drive, Orlando, Florida 32835 90 count
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0348-2014·2013-12-04

    Ortho Molecular Products Recalls DigestzymeV. Due to Chloramphenicol Contamination

    Ortho Molecular Products is recalling DigestzymeV. dietary supplements because the vegetable enzyme raw material may be contaminated with chloramphenicol.

    Product
    Ortho Molecular Products DigestzymeV. Dietary Supplement. Gastrointestinal health. 90 (product code 128090 and 128090U) and 180 capsules (product code 128180 and 128180U).
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0394-2014·2013-12-04

    Synthes Spiked Washers Recalled Due to Mislabeled Size

    Synthes USA HQ, Inc. is recalling Spiked Washers 13.5/6.5 because they were mislabeled as 13.5/5.5 during a retrospective assessment.

    Product
    Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0400-2014·2013-12-04

    Lanx Recalls Timberline MPF Straight Split Tip Driver Due to Sizing Defect

    Lanx, Inc. is recalling 25 units of the Timberline MPF Straight Split Tip Driver - Short because the tip is oversized.

    Product
    LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 8630-0107. The Timberline MPF device is an intervertebral body fusion device consisting of a PEEK intervertebral spacer, titanium plate, and screws. The PEEK…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0398-2014·2013-12-04

    Medtronic Recalls Delta Shunt Assembly Kits Due to Label Discrepancies

    Medtronic Neurosurgery is recalling Delta Shunt Assembly Kits because label discrepancies were found. The recall covers 34 units distributed worldwide.

    Product
    Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201. Delta Shunt Assemblies are designed for use in shunting CSF from the lateral ventricle of the brain into the peritoneal cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0400-2014·2013-12-04

    Kraft and Polly-O String Cheese Recalled for Potential Spoilage

    Kraft Foods Group is recalling specific varieties of Kraft and Polly-O String Cheese and String Cheese Twist products that may spoil before their expiration dates, causing discoloration.

    Product
    Mozzarella String Cheese made with 2% milk for 1/4 less fat, sold under Kraft brand or Polly-O brand and packaged with either 12 or 24 pieces of mozzarella cheese individually wrapped in plastic and sold in a plastic bag with a net weight respectively of 10 oz. (283g) or 20 oz.…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0384-2014·2013-12-04

    Synthes Matrix Threaded Persuader Recalled Due to Reduction Insert Breakage

    Synthes USA HQ, Inc. is recalling 634 units of the Matrix Threaded Persuader because the Reduction Insert can break during use, preventing the instrument from functioning.

    Product
    Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to provide flexibility biomechanical performance and a solution to complex posterior pathological challenges.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0387-2014·2013-12-04

    Synthes Large Buttress Compression Nut Recalled for Threading Defect

    Synthes USA is recalling 135 Large Buttress Compression Nuts for Blade Guide Sleeve TFN because the nuts did not thread completely and became stuck.

    Product
    Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations there of.
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Food)·F-0229-2014·2013-12-04

    Florayme A Dietary Supplement Recalled for Chloramphenicol Contamination

    FoodScience Corporation is recalling Florayme A dietary supplements because they may contain trace amounts of the antibiotic chloramphenicol.

    Product
    Florayme A Dietary Supplement for Complete Digestive Support, 90 count capsules Distributed by Wendy Huang, MD, MPH, DABMA 9 Professional Circle, Suite 212, Colts Neck, NJ 07722
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0402-2014·2013-12-04

    Kraft and Polly-O String Cheese Recalled for Potential Spoilage

    Kraft Foods Group is recalling specific varieties of Kraft and Polly-O String Cheese and String Cheese Twist products because they may spoil before their 'Best When Used By' dates, causing discoloration.

    Product
    Low-Moisture Part-Skim Mozzarella String Cheese With Tomato and Basil, sold under Kraft brand or Polly-O brand and packaged with 12 pieces of mozzarella cheese with tomato and basil individually wrapped in plastic and sold in a plastic bag with a net weight of 10 oz. (283g).
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0397-2014·2013-12-04

    Medtronic Recalls CSF-Unitized Shunts Due to Label Discrepancies

    Medtronic Neurosurgery is recalling CSF-Unitized Shunts, Delta Shunt Assembly Kits, and Strata II Shunt Assembly Kits due to label discrepancies.

    Product
    CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Regular, High Pressure, Catalog No. 46026. CSF-Unitized Shunt Kits are designed as integrated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0402-2014·2013-12-04

    Advanced Sterilization Products Recalls STERRAD Sterilization Systems

    Advanced Sterilization Products is recalling STERRAD NX and 100NX sterilizers because bronchoscopes may contain unlisted polyurethane material in the suction channel.

    Product
    STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0393-2014·2013-12-04

    Synthes Material Mix Surgical Instruments Recalled Due to Material Error

    Synthes USA is recalling approximately 44 surgical instruments because a material batch was mixed with an incorrect material having lower hardness and corrosion resistance.

    Product
    Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Material Mix: Adjustable Cervical Distractor-Right is used to distract spine segment. Matrix Distractor Rack is used to distract the interbody…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0227-2014·2013-12-04

    Nutritional Frontiers Cyb Zyme Recalled for Chloramphenicol Contamination

    FoodScience Corporation is recalling Nutritional Frontiers Cyb Zyme dietary supplements because they may contain trace amounts of the antibiotic chloramphenicol.

    Product
    Nutritional Frontiers Cyb Zyme- A Dietary Supplement for Complete Digestive Support 90 count
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0382-2014·2013-12-04

    Southern Implants Recalls Tri-Nex Healing Abutments Due to Labeling Error

    Southern Implants is recalling 197 Tri-Nex healing abutments because the packages were incorrectly labeled and contained the wrong product size.

    Product
    Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. The NSI Implant System is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-022-2014·2013-12-04

    Novartis Recalls Loratadine Tablets Due to Chipped and Broken Pieces

    Novartis Consumer Health is recalling 11.8 million loratadine 10 mg antihistamine blister packs sold nationwide under seven different store brands because the tablets are chipped or broken.

    Product
    Loratadine, USP 10 mg, Antihistamine, packaged in blister packs. All manufactured by Novartis Consumer Health, Inc, Lincoln, NE / There are 7 different labels under which this product is packaged but the active ingredient is the same. 1) DOLLAR GENERAL LABEL: DG Health…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0383-2014·2013-12-04

    Thermo Fisher Recalls MAS Urinalysis Control Level 1 for Stability Failure

    Thermo Fisher Scientific is recalling 914 units of MAS Urinalysis Control Level 1 because the product failed to meet 30-day open vial stability specifications.

    Product
    MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222; Product is manufactured and distributed by Microgenics Corporation, a subsidiary of Thermo Fisher Scientific, Clinical Diagnostic Division, Fremont, CA MAS Urinalysis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0428-2014·2013-12-04

    3M Recalls Unitek Stainless Steel Crowns Due to Mislabeling

    3M is recalling specific lots of Unitek Primary Stainless Steel Crowns because LL3 crowns were incorrectly labeled as UR4 crowns.

    Product
    3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth.
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-0386-2014·2013-12-04

    Lin-Zhi International Recalls Norbuprenorphine Urine Control Material

    Lin-Zhi International is recalling Norbuprenorphine Level 2 Controls because the analyte degrades, causing decreased concentration readings.

    Product
    Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. Manufacturer: Lin-Zhi International…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0407-2014·2013-12-04

    Synthes Titanium Humeral Nail Recalled for Incorrect Packaging Labeling

    Synthes USA is recalling 14 Titanium Cannulated Humeral Nails because the packaging incorrectly depicts the device as having 3 distal holes instead of 2.

    Product
    Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-020-2014·2013-12-04

    Valeant Recalls Acanya Gel Samples Due to Incorrect Expiration Date

    Valeant Pharmaceuticals is recalling 45,000 tubes of Acanya gel physician samples because they were assigned an incorrect expiration date.

    Product
    Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel 1.2% and 2.5%, Net Wt. 3.5 g, Rx Only, Sample - not for sale, CORIA Laboratories, a division of Valeant Pharmaceuticals LLC, Bridgewater, NJ 08807 --- NDC 13548-132-03
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-0379-2014·2013-12-04

    Alere Cholestech LDX Lipid Profile-GLU Test Cassettes Recalled for Labeling Error

    Alere San Diego, Inc. is recalling 3,621 kits of Cholestech LDX Lipid Profile-GLU test cassettes because an incorrect lot number was printed on the packaging.

    Product
    Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette, Model 10-991. Product Generic Name: Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette. Description of the product: Lipid. Glucose panel Test cassettes. Product packaging: 10 individually pouched…
    Category
    Medical Device
    Distribution
    Distributed nationwide

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