BEUDAMED
    FDA Recall Terminated

    Sterile Custom Packs to be used in surgical procedures.

    Recall: Z-2179-2020 · Initiated April 13, 2020

    Recall

    Recall Number
    Z-2179-2020
    Event Number
    85502
    Firm
    American Contract Systems Jackson Pointe Commerce
    FEI Number
    3011389083
    Product Code
    PKE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 13, 2020
    Terminated
    November 25, 2020
    Address
    4050 Jacksons Pointe Ct, Zelienople, PA, 16063-2838

    Description

    Sterile Custom Packs to be used in surgical procedures.

    Reason

    The surgical gowns were manufactured in a facility that is not registered by the FDA.

    Action

    Notification to the distributor and instructed them to notify its customers (hospitals) of the recall and product removal.

    Distribution

    US Nationwide distribution including in the state of Pennsylvania.

    Quantity

    2,868 total kits