The Recall Desk

Archive

September 2013 recalls

530 recalls were announced in September 2013.

What the numbers show

Critical
15
Severe
184
High
234
Moderate
81
Low
16

Of the 530 recalls this month scored against our rubric, 3% are Critical, 35% are Severe.

Which agencies issued them

501–530 of 530

  • ModerateFDA (Devices)·Z-2106-2013·2013-09-04

    Medtronic Perfusion Tubing Packs Recalled Due to Component Issue

    Medtronic is recalling specific Perfusion Tubing Packs because they contain Rigid Suction Wands that are subject to a separate recall by Edwards Lifesciences.

    Product
    Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin). Model Numbers: TL4X17R8, TL5D01R, TL5D02R, TL5D02R3, TL5D02R5, and TL6A65R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: This product is indica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2087-2013·2013-09-04

    Synthes 2.4 mm VA-LCP Distal Radius Plate Recall for Mislabeling

    Synthes USA HQ, Inc. is recalling 11 units of 2.4 mm VA-LCP distal radius plates that may be incorrectly etched with 'R' instead of 'L'.

    Product
    Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-and extra-articular fractures and osteotomies of the distal radius and other small bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1862-2013·2013-09-04

    Long Life Premium Organic Green Tea Recalled for Possible Lemongrass Contamination

    Custom Co-Pak is recalling Long Life Premium Organic Green Tea with Lemongrass due to possible contamination in the lemongrass ingredient.

    Product
    Long Life Premium Organic Green Tea with Lemongrass, packages of 18 tea bags, (27 grams/.95 ounces)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2053-2013·2013-09-04

    Sarken STAT! 1-Panel Test Kit Recalled for Inadequate Labeling

    Sarken, Inc. is recalling STAT! 1-Panel Test Kits because they were distributed without adequate labeling and instructions, which could lead to misuse and incorrect results.

    Product
    SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2111-2013·2013-09-04

    Becton Dickinson PrepStain Tecan US-I Recall for Incorrect Rack Settings

    Becton Dickinson is recalling 890 PrepStain Tecan US-I instruments because a rack setting was incorrectly entered during routine maintenance.

    Product
    PrepStain Tecan US-I. For use in the screening and detection of cervical cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2049-2013·2013-09-04

    Sarken STAT! Multi-Drug Test Panel Recalled for Inadequate Labeling

    Sarken, Inc. is recalling STAT! Multi-Drug Test Panels because they were distributed without adequate labeling and instructions for use, which could lead to misuse and incorrect test results.

    Product
    SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2060-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Reconstruction Prosthesis

    Waldemar Link is recalling four trial stems for a reconstruction prosthesis because they were manufactured using the wrong design.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, prox. Stem dia. 12 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2083-2013·2013-09-04

    Brainlab Frameless SRS QA Target Pointer Cap Recall

    Brainlab AG is recalling 6 units of the Frameless SRS QA Target Pointer because the pointer cap may become loose under moderate force.

    Product
    BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures. The Frameless Radiosurgery Components are a device u
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2059-2013·2013-09-04

    Philips Easy Upgrade DR Recalled for Potential Image Marker Misinterpretation

    Philips Healthcare is recalling 89 Easy Upgrade DR systems because a mirror icon on images could be misinterpreted as a right lead marker if the image is mirrored in a PACS system.

    Product
    Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2047-2013·2013-09-04

    Siemens PSA Assay Kits Recalled for Positive Bias in Results

    Siemens Healthcare Diagnostics is recalling PSA Assay kits for use in IMMULITE systems due to a confirmed positive bias of 20% to 23% in patient results.

    Product
    PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D); and in the IMMULITE 2000/2000XPi Systems Analyzers, Catalog Numbers L2KPS2, L2KPS6, L2KPTS2(D) and L2KPTS6(D). IVD Immunoassay kits in the following sizes: 100, 200, 5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2045-2013·2013-09-04

    Pipeline Embolization Device Recalled for Missing Contraindication Information

    Micro Therapeutics Inc is recalling 62 Pipeline Embolization Devices because the instructions for use are missing specific contraindications regarding pre-existing stents and medication designations.

    Product
    Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophys
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-2112-2013·2013-09-04

    Becton Dickinson PrepStain Tecan US-II Recall for Incorrect Rack Setting

    Becton Dickinson is recalling 890 PrepStain Tecan US-II instruments because a rack setting was incorrectly entered during routine maintenance.

    Product
    PrepStain Tecan US-II. For use in the screening and detection of cervical cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2110-2013·2013-09-04

    Becton Dickinson PrepStain AG System Recall for Incorrect Rack Setting

    Becton Dickinson is recalling 890 PrepStain AG systems because a rack setting was incorrectly entered during routine maintenance.

    Product
    PrepStain AG. For use in the screening and detection of cervical cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2048-2013·2013-09-04

    Sarken STAT! Multi-Drug Test Panel Recalled for Inadequate Labeling

    Sarken, Inc. is recalling STAT! Multi-Drug Test Panels because they were distributed without adequate labeling and instructions for use, which could lead to misuse and incorrect test results.

    Product
    SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2108-2013·2013-09-04

    Siemens Axiom Artis C-arm Systems Recalled for Incorrect Channel Nuts

    Siemens Medical Solutions USA is recalling 178 Axiom Artis C-arm angiographic x-ray systems because third-party installers may have used incorrect channel nuts.

    Product
    Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2103-2013·2013-09-04

    SpineNet Anterior Cervical Cage Recalled for Incorrect Instructions for Use

    SpineNet is recalling 400 anterior cervical cages because the instructions for use contained statements that should have been removed prior to marketing.

    Product
    SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) Product Usage: Is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc lev
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2099-2013·2013-09-04

    Stryker Recalls Asnis III Cannulated Screws Due to Incorrect Length

    Stryker is recalling 23 units of Asnis III Cannulated Screws because the length of the device was reported to be incorrect.

    Product
    Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S 4.0x42mm TL 14mm, sterile Product Usage: The Asnis III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2070-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Reconstruction Prosthesis

    Waldemar Link is recalling five trial stems for a reconstruction prosthesis because they were manufactured using the wrong design. The units were distributed only to Tennessee.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/18, Stem size 03, prox. Stem dia. 18 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2052-2013·2013-09-04

    Sarken STAT! 1-Panel Test Kit Recalled for Inadequate Labeling

    Sarken, Inc. is recalling STAT! 1-Panel Test Kits because they were distributed without adequate labeling and instructions, which could lead to misuse and incorrect test results.

    Product
    SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2058-2013·2013-09-04

    Synthes Trauma Nail System Recalled for Potential Outer Pouch Compromise

    Synthes USA HQ, Inc. is recalling Trauma Nail Systems because the outer packaging pouch may be compromised, potentially affecting the sterile internal pouch.

    Product
    Synthes Trauma Nail System. The devices are indication for bone fixation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2101-2013·2013-09-04

    Zimmer Recalls Distal Medial Humeral Locking Plates Due to Labeling Error

    Zimmer is recalling specific lots of Distal Medial Humeral Locking Plates because the Chinese labels incorrectly identify right-sided implants as left-sided.

    Product
    ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLATE, SHORT RIGHT 11 HOLES 178 MM LENGTH STERILE RX ONLY Product Usage: Usage: The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotom
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2118-2013·2013-09-04

    Ventana BenchMark and Discovery Instruments Recalled for Heating Element Defect

    Ventana Medical Systems is recalling BenchMark and Discovery instruments because a heating element may separate, causing inconsistent staining without an error message.

    Product
    Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. Product Usage: Usage: The Benchmark product lines are intended to automatically stain histological or cytological specimens on microscope slides with spe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2057-2013·2013-09-04

    Synthes VA-LCP Distal Radius Plate Labeling Recall

    Synthes (USA) Products LLC is recalling 119,891 units of 2.4mm VA-LCP Two Column Volar Distal Radius Plates due to a labeling error in the US Technique guide.

    Product
    Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2096-2013·2013-09-04

    Celera OLA Buffer Recalled for Incorrect Concentration Units

    Celera Corporation is recalling OLA Buffer for Laboratory Use because the package insert listed the wrong concentration units.

    Product
    OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 ¿M) and KCL (300 ¿M. 10.0ml.) PN: 50003300; Store at d - 15¿C. Product Usage: General Purpose Reagent for laboratory use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2081-2013·2013-09-04

    Remel Recalls Oxoid Nitrofurantoin Antimicrobial Susceptibility Test Discs

    Remel Inc is recalling specific lots of Oxoid Nitrofurantoin test discs because they may provide false susceptibility results.

    Product
    Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England Product is used in the semi-quantitative agar diffusion test me
    Category
    Medical Device
    Distribution
    17 states
  • LowFDA (Food)·F-1860-2013·2013-09-04

    Nature's Earthly Choice Organic Quinoa Recalled for Sand and Grit

    Global Juices & Fruits LLC is recalling Nature's Earthly Choice Organic Quinoa because it may contain sand and grit.

    Product
    Nature's Earthly Choice Organic Quinoa Distributed by Nature's Earthly Choice Eagle, ID 83616 Product of Bolivia a) Net Wt 2 lbs. - UPC 897034002267 b) Net Wt 4 lbs.- UPC 897034002021 packaged in re-sealable bags
    Category
    Food
    Distribution
    2 states
  • SevereCPSC·13275·2013-09-03

    Target Recalls White Floor Lamps Due to Fire and Shock Hazard

    Target is recalling approximately 25,000 white floor lamps sold in the U.S. and Canada due to a fire and shock hazard. Consumers should stop using the lamps and return them for a refund.

    Product
    White 2-Bulb Floor Lamp
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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