The Recall Desk

Archive

December 2015 recalls

614 recalls were announced in December 2015.

What the numbers show

Critical
17
Severe
229
High
195
Moderate
132
Low
41

Of the 614 recalls this month scored against our rubric, 3% are Critical, 37% are Severe.

Which agencies issued them

601–614 of 614

  • ModerateFDA (Devices)·Z-0329-2016·2015-12-02

    Palindrome Chronic Catheter Kit Recalled for Packaging Defect

    Covidien LLC is recalling 280 units of Palindrome Chronic Catheter Kits because they were incorrectly packaged with a 90-degree bend at the distal tip.

    Product
    Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0326-2016·2015-12-02

    Cranberry Chipotle Spread Recalled for Potential Mold Contamination

    Something Special Deli-Foods Ltd. is voluntarily recalling Cranberry Chipotle Spread due to the potential for mold.

    Product
    Cranberry Chipotle Spread, 10.5 oz, packed in glass jar with metal lid, inside a cardboard box
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0330-2016·2015-12-02

    Palindrome Precision Chronic Catheter Kit Recalled for Packaging Defect

    Covidien LLC is recalling 160 units of Palindrome Precision Chronic Catheter Kits because they were incorrectly packaged with a 90-degree bend at the distal tip.

    Product
    Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145017P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0341-2016·2015-12-02

    Leica Microsystems Recalls Unstable CD10 Monoclonal Antibody Diagnostic Reagents

    Leica Microsystems is recalling specific lots of Novocastra CD10 antibody reagents because they are not stable up to the labeled expiry date.

    Product
    Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by light microscopy of CD10 molecules in paraffin sections.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0334-2016·2015-12-02

    BD CD64 APC-R700 Reagent Recalled Due to CD4 Antibody Contamination

    Becton, Dickinson and Company is recalling three lots of CD64 APC-R700 reagent because they are contaminated with CD4 antibody, which may cause unexpected staining patterns.

    Product
    BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent - contamination leads to possibility of unexpected staining pattern.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0325-2016·2015-12-02

    Philips MRI Systems Recalled for Reversed Image Order in MobiView Software

    Philips is recalling specific MRI systems with MobiView software due to a defect that reverses the order of fused multi-station scan images.

    Product
    Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0322-2016·2015-12-02

    Lab Vision p21 WF1 Antibody Recalled for Incorrect Concentration Labeling

    Lab Vision Corporation is recalling p21 WF1 Ab-3 antibody vials because the label incorrectly states the concentration as 0.2 mg/ml instead of the actual 0.4 mg/ml.

    Product
    Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS-230-P and MS-230P0; Hematology: p21WAF1/Cip1/Sdi1/Pic1 is a tumor suppressor protein. Expression of p21WAF1 is induced by wild type, but not mutant, p53 suppressor protein. The p21WAF1 protein binds…
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-0328-2016·2015-12-02

    Biochemical Diagnostics Recalls hCG Control Kits Due to Labeling Discrepancies

    Biochemical Diagnostics Inc. is recalling CONSULT hCG Controls Kits because storage temperature instructions on the kit labels do not match the vial labels and package insert.

    Product
    CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0323-2016·2015-12-02

    Synthes 2.4mm Locking Screws Recalled for Incorrect Package Insert

    Synthes (USA) Products LLC is recalling 229 units of 2.4mm Locking Screws because they may contain the wrong package insert.

    Product
    2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
    Category
    Medical Device
    Distribution
    27 states
  • HighNHTSA·15V808000·2015-12-01

    Newmar Recalls Motorhomes Due to Refrigerator Door Latch Defect

    Newmar is recalling specific motorhomes because refrigerator door latches may lock without the operator's knowledge, posing a risk of injury if a person is trapped inside.

    Product
    NEWMAR — NEWMAR VENTANA, VENTANA LE, CANYON STAR, DUTCH STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V810000·2015-12-01

    Altec Recalls 2011-2015 Brush Chippers Due to Weld Defects

    Altec is recalling 2011-2015 DSC6 and DC610 brush chippers because improper welds or incorrect spacers may cause the anvil to detach, posing an injury risk.

    Product
    ALTEC — ALTEC DSC6 BRUSH CHIPPER, DC610 BRUSH CHIPPER
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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