BEUDAMED
    FDA Recall Open, Classified

    Various products which were contract sterilized.

    Recall: Z-0259-2020 · Initiated May 23, 2019

    Recall

    Recall Number
    Z-0259-2020
    Event Number
    83001
    Firm
    Anewmed Corporation
    FEI Number
    3009711423
    Product Code
    DQX
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    May 23, 2019
    Address
    2177 Flintstone Dr, Ste O, Tucker, GA, 30084-5000

    Description

    Various products which were contract sterilized.

    Reason

    The contract sterilizer did not have adequate packaging data to support the 2-year shelf life.

    Action

    AnewMed Corporation notified customers on about 05/23/2019 via "URGENT NOTICE VOLUNTARY RECAL OF MEDICAL DEVICES" letter sent certified mail. Instructions included to examine inventory for affected devices and either return them to AnewMed for a credit or destroy them. Customers were also instructed to complete and return the provided Reply Card and indicate whether devices will be return or have been discarded. Questions or additional details can be obtained from Rob Bennison or Nykysha Anderson at 770-263-9633, Monday-Friday, 8:30 AM to 4:40 PM Eastern Time.

    Distribution

    Nationwide distribution in the states of AL, CO, FL, IN, KY, MS, NC, OH, SC, TN, TX.

    Quantity

    1,749 devices