BEUDAMED
    FDA Recall Terminated

    BASIN SET, MEBS42K, general surgical kit

    Recall: Z-0274-2023 · Initiated October 12, 2022

    Recall

    Recall Number
    Z-0274-2023
    Event Number
    91077
    Firm
    American Contract Systems, Inc.
    FEI Number
    3003419114
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 12, 2022
    Posted
    November 22, 2022
    Terminated
    March 6, 2025
    Address
    2610 Ne Industrial Dr, Ste 220, Kansas City, MO, 64117-2648

    Description

    BASIN SET, MEBS42K, general surgical kit

    Reason

    Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the contents of the package do not match the contents listed on the label.

    Action

    The firm issued an URGENT: MEDICAL DEVICE FIELD CORRECTION notice to their consignees by email on 10/12/2022. The notice explained the issue and requested the following actions be taken: "Please review your inventory, and segregate and quarantine all affected Kits. If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified of this product recall and maintain records of effectiveness. If you received any of the batches listed in this notification letter, please contact [email protected] for a replacement kit."

    Distribution

    US Nationwide distribution.

    Quantity

    1504 trays