BEUDAMED
    FDA Recall Terminated

    GAUZE SPONGE 4"X4" 16 PLY XRD 1280/CS (STERILE) Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    Recall: Z-2685-2015 · Initiated July 10, 2015

    Recall

    Recall Number
    Z-2685-2015
    Event Number
    71721
    Firm
    Customed, Inc Calle Igualdad Final # 7
    FEI Number
    2648727
    Product Code
    EFQ
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    July 10, 2015
    Posted
    September 3, 2015
    Terminated
    April 12, 2017
    Address
    Fajardo, PR, 00738

    Description

    GAUZE SPONGE 4"X4" 16 PLY XRD 1280/CS (STERILE) Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    Reason

    Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

    Action

    Customed issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" notification letter dated July 10, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.

    Distribution

    Distributed Only in Puerto Rico.

    Quantity

    25471.94