BEUDAMED
    FDA Recall Terminated

    Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (b) CMS-5832-R1 Custom Safety Mammo Biopsy Tray (c) CMS-4108 Multipurpose Safety Tray (d) CMS-3141-R6 Custom Ultrasound Tray (e) CMS-2891-R1 Custom Safety Biopsy Tray (f) CMS-5798-R1 Custom Safety Biopsy Tray (g) CMS-2357R2 Custom Biopsy Tray (h) CMS-2540-R4 Custom Biopsy Tray

    Recall: Z-3059-2017 · Initiated June 15, 2017

    Recall

    Recall Number
    Z-3059-2017
    Event Number
    77962
    Firm
    Custom Assemblies Inc
    FEI Number
    3000718854
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    June 15, 2017
    Posted
    August 22, 2017
    Terminated
    August 28, 2017
    Address
    330 E. Main Street, Pine Level, NC, 27568

    Description

    Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (b) CMS-5832-R1 Custom Safety Mammo Biopsy Tray (c) CMS-4108 Multipurpose Safety Tray (d) CMS-3141-R6 Custom Ultrasound Tray (e) CMS-2891-R1 Custom Safety Biopsy Tray (f) CMS-5798-R1 Custom Safety Biopsy Tray (g) CMS-2357R2 Custom Biopsy Tray (h) CMS-2540-R4 Custom Biopsy Tray

    Reason

    The firm manufactured and distributed custom surgical kits which contained BD SafetyGlide" 22GA 1 inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection.

    Action

    BD sent an Urgent Medical Device Recall letter dated June 12, 2017, to all affected consignees. Consignees were instructed to examine their inventory and quarantine any affected product. Consignees with questions should call 201-847-4267. For questions regarding this recall call 919-202-8462.

    Distribution

    Nationwide Distribution to NJ, TN, NY, KS, OH, CA,

    Quantity

    2155 kits