BEUDAMED
    FDA Recall Terminated

    3M nexcare First Aid HoldFast Roll Gauze cat # HR-2R Lot # 4267. 3M Health Care St. Paul, MN 55144-1000. 1 Roll, 2 in. x 4.1 yards (stretched). Immediate product packaging (formed plastic with paper cover) contains no labeling.

    Recall: Z-0264-05 · Initiated November 5, 2004

    Recall

    Recall Number
    Z-0264-05
    Event Number
    30407
    FEI Number
    2110898
    Product Code
    FRO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 5, 2004
    Posted
    November 30, 2004
    Terminated
    November 17, 2005
    Address
    Bldg 275-05-W-06 3M Company Medical Division 3M Center, South St Paul, MN, 55411

    Description

    3M nexcare First Aid HoldFast Roll Gauze cat # HR-2R Lot # 4267. 3M Health Care St. Paul, MN 55144-1000. 1 Roll, 2 in. x 4.1 yards (stretched). Immediate product packaging (formed plastic with paper cover) contains no labeling.

    Reason

    Mislabeled - Nexcare Holdfast Roll Gauze were not sterilized, the product is labeled with 'Sterility Guaranteed Unless Package is Opened or Damaged'

    Action

    3M sent letter dated 11/05/04 to distributors asking distributors to notify their customers immediately who received this lot number. A sample notification letter was also included to the distributors for instructing the retail location to return product to 3M.

    Distribution

    Product sent to 38 retail healthcare product distributors located throughout the US and guam. States include MN, IL, MO, CO, TX, PA, MA, MD, NJ, NY, GA, NC, SC, WA, CA and Hawaii

    Quantity

    147 cases. each case represents 24 rolls. for a total of 3528 rolls