BEUDAMED
    FDA Recall Terminated

    ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection Large, Cat #901015, UPC 0 51131019985 9

    Recall: Z-0552-2018 · Initiated November 1, 2017

    Recall

    Recall Number
    Z-0552-2018
    Event Number
    78444
    Firm
    3M Company Health Care Business 3m Center
    FEI Number
    2110898
    Product Code
    NOC
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    November 1, 2017
    Terminated
    July 22, 2020
    Address
    2510 Conway Ave, B # 275-5-W-6, Saint Paul, MN, 55144-0001

    Description

    ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection Large, Cat #901015, UPC 0 51131019985 9

    Reason

    Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus.

    Action

    The firm initiated their recall on 11/01/2017 by letter. The letter requested the consignee cease distribution of the recalled product, isolate it pending return. Distributors were asked to notify their customers including a copy of the 3M recall notice.

    Distribution

    AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MO, MS, NC, NH, NY, OH, OR, PA, SC, TN, TX, UT, VA, WI, WV

    Quantity

    996 units