BEUDAMED
    FDA Recall Terminated

    3M Nexcare First Aid High Performance Gauze Pad. Individually wrapped & sterile. catalog # 434-10. 3M Consumer Health Care, St. Paul, MN 55144-1000. Made in USA. UPC 05113166774.

    Recall: Z-1234-06 · Initiated February 9, 2006

    Recall

    Recall Number
    Z-1234-06
    Event Number
    34633
    FEI Number
    2110898
    Product Code
    FRL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 9, 2006
    Posted
    July 13, 2006
    Terminated
    January 5, 2007
    Address
    Bldg 275-05-W-06 3M Company Medical Division 3M Center, South St Paul, MN, 55411

    Description

    3M Nexcare First Aid High Performance Gauze Pad. Individually wrapped & sterile. catalog # 434-10. 3M Consumer Health Care, St. Paul, MN 55144-1000. Made in USA. UPC 05113166774.

    Reason

    After reviewing manufacturing records it has been determined that these lots inadvertently were not sterilized after packaging in individual boxes labeled as sterile product.

    Action

    All product in house and at the distributors was put on hold at the time of discovery. Distributors were contacted by telephone between 2/7/06 & 2/8/06 and asked to hold product from affected lots. Recall Letters to distributors dated 2/9/06 were faxed and mailed via UPS next day air on 2/9/06.

    Distribution

    Nationwide, with distributors in CA, LA, MI, NJ, OH.

    Quantity

    432 boxes