BEUDAMED
    FDA Recall Terminated

    3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM.

    Recall: Z-0601-2016 · Initiated December 1, 2015

    Recall

    Recall Number
    Z-0601-2016
    Event Number
    72780
    Firm
    3M Company Health Care Business 3m Center
    FEI Number
    2110898
    Product Code
    FMP
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 1, 2015
    Terminated
    May 24, 2016
    Address
    2510 Conway Ave, B # 275-5-W-6, Saint Paul, MN, 55144-0001

    Description

    3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM.

    Reason

    Product mislabeled as latex free. Actual Catalog number 1581, lot 2020-10AN. contains latex. This could pose a health risk to users with sensitivity or allergic reaction to latex, which could range from mild to severe.

    Action

    Consignees were sent via certified mail on 12/1/2015 a 3M letter dated November 25, 2015 and an emal on 12/5/2015 for the updated 3M "Urgent Medical Device" letter dated November 25, 2015. The letter was addressed to 3M Health Care Distributor. The letter described the problem, device involved in the recall and the action required. Advised consignees to quarantine the product, notify their customers and to complete and return the "Product Recall Form". Distributors were also provided with a "Customer" letter for distribution. For questions contact 3M Customer Helpline 1-800-228-3957.

    Distribution

    US nationwide distribution.

    Quantity

    167 cases (30 rolls/case)