BEUDAMED
    FDA Recall Open, Classified

    Surgical Suture Kit

    Recall: Z-1132-2022 · Initiated April 22, 2022

    Recall

    Recall Number
    Z-1132-2022
    Event Number
    90059
    Firm
    Stradis Healthcare
    FEI Number
    1450943
    Product Code
    MCZ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 22, 2022
    Address
    3600 Burwood Dr, Waukegan, IL, 60085-8399

    Description

    Surgical Suture Kit

    Reason

    There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.

    Action

    The firm, Stradis Health, initiated an "URGENT: MEDICAL DEVICE RECALL" on 04/22/2022 via email. The letter instructs the consignee to examine your inventory and immediately quarantine any affected product; contact Stradis Customer Service to arrange or return, shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Service can be reached at 1-800-886-7257 or by email at [email protected]. Notify their customer within 48 hours and the customers should contact the firm to arrange for a return. The firm is also requesting that the consignees return an acknowledgement form. If you have any questions regarding this notification, please do not hesitate to contact us at 1-800-886-7257.

    Distribution

    US Distribution to NC.

    Quantity

    7340 units