BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported March 1, 2017

    Enforcement

    Recall Number
    Z-1234-2017
    Event ID
    76276
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Custom Medical Specialties, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 1, 2017
    Initiation Date
    September 20, 2016
    Classification Date
    February 22, 2017
    Address
    330 East Main Street, N/A, Pine Level, NC, 27568, United States

    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.

    Code Info

    Lots 40629-1609 an 40631-1609

    Distribution

    US Distribution to ID and OR.

    Quantity

    80 syringes