BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported December 12, 2018

    Enforcement

    Recall Number
    Z-0525-2019
    Event ID
    81555
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ASO, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 12, 2018
    Initiation Date
    October 16, 2018
    Classification Date
    November 30, 2018
    Address
    300 Sarasota Center Blvd, N/A, Sarasota, FL, 34240-9381, United States

    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

    Code Info

    ASO Item No. 780655, Batch/Lot # 2384-20180524

    Distribution

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

    Quantity

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