BEUDAMED
    FDA Recall Open, Classified

    Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 count cardboard box

    Recall: Z-0525-2019 · Initiated October 16, 2018

    Recall

    Recall Number
    Z-0525-2019
    Event Number
    81555
    Firm
    ASO, LLC
    FEI Number
    1038758
    Product Code
    NAB
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 16, 2018
    Address
    300 Sarasota Center Blvd, Sarasota, FL, 34240-9381

    Description

    Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 count cardboard box

    Reason

    Potential that gauze pads may not be fully sterilized

    Action

    ASO, LLC notified customers of the recall on about 10/16/2018 via "URGENT: MEDICAL DEVICE RECALL" letter sent to corporate. Instructions were to immediately stop using/distributing the affected gauze pads, place them in quarantine, and return to ASO LLC. Customers were also instructed to complete and return the response form.

    Distribution

    Distributed nationwide to AR, FL, IA, IN, KY, NY, OK, TX, UT, VA.

    Quantity

    218 cases (72, 10-ct boxes per case)