BEUDAMED
    FDA Recall Terminated

    FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6

    Recall: Z-0945-2018 · Initiated January 31, 2018

    Recall

    Recall Number
    Z-0945-2018
    Event Number
    79051
    Firm
    3M Company Health Care Business 3m Center
    FEI Number
    2110898
    Product Code
    IQI
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    January 31, 2018
    Terminated
    February 11, 2021
    Address
    2510 Conway Ave, B # 275-5-W-6, Saint Paul, MN, 55144-0001

    Description

    FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6

    Reason

    3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The products contain natural latex rubber, but do not include the appropriate caution statement.

    Action

    The firm initiated their recall by letter on 01/30/2018. The letter stated the following: "Actions required: 1. Immediately discontinue sale of Futuro" Quick Strap Ankle Brace. 2. Isolate or quarantine any stock of the Futuro" Quick Strap Ankle Brace. 3. Call 1-866-746-2524, option #2, Monday to Friday, 8:00 am 4:30 pm Central time, to arrange for the return of the Futuro" Quick Strap Ankle Brace, Cat# 47736EN. 4. If you have further distributed the Futuro" Quick Strap Ankle Brace, please notify any of your customers at once. Please include a copy of this letter in your communications. We apologize for any inconvenience this may cause you. Should you have any questions regarding the product and return process, please feel free to contact 3M Customer Service at 1-866-746-2524, option 2, Monday to Friday, 8:00 am 4:30 pm Central Time."

    Distribution

    US and Australia, Jordan, Republic Of Korea, Lebanon, New Zealand, Oman, Qatar, Taiwan, United Arab Emirates

    Quantity

    158,179 units