BEUDAMED
    FDA Recall Open, Classified

    Remington MEDICAL Drainage Bag, REF 600-D;

    Recall: Z-0487-2024 · Initiated November 3, 2023

    Recall

    Recall Number
    Z-0487-2024
    Event Number
    93377
    Firm
    Remington Medical, Inc.
    FEI Number
    1000132370
    Product Code
    EXF
    Status
    Open, Classified
    Root Cause
    Labeling mix-ups
    Initiated
    November 3, 2023
    Posted
    December 5, 2023
    Address
    6830 Meadowridge Ct, Alpharetta, GA, 30005-2202

    Description

    Remington MEDICAL Drainage Bag, REF 600-D;

    Reason

    There is an error with the "Use by Date" and "Date of Manufacturer" on the box label.

    Action

    Remington Medical issued an URGENT: RECALL NOTIFICATION LETTER to its consignees on 11/03/2023 via email. The notice explained the issue, the potential risk, and requested the notice be communicated to all parties to whom it was distributed. If allowed by the consignee's internal procedures, remove the pouches from the box, as the pouch label correctly identifies the actual Date of Manufacture date and Use By date. The firm will replace the affected devices.

    Distribution

    US: PA and FL

    Quantity

    3080 devices