BEUDAMED
    FDA Recall Open, Classified

    CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.

    Recall: Z-1234-2017 · Initiated September 20, 2016

    Recall

    Recall Number
    Z-1234-2017
    Event Number
    76276
    Firm
    Custom Medical Specialties, Inc.
    FEI Number
    3005474845
    Product Code
    FCH
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 20, 2016
    Address
    330 East Main Street, Pine Level, NC, 27568

    Description

    CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.

    Reason

    Sterility of syringe product could not be assured.

    Action

    A letter was issued to customers on 9/20/2016 notifying them of the recall of the 10 cc syringe by BD. The letter tells them not to use the syringe in the kit, and to use the syringe on the outside of the kit which is not part of the recall.

    Distribution

    US Distribution to ID and OR.

    Quantity

    80 syringes