BEUDAMED
    FDA Recall Terminated

    3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, 1590B-136

    Recall: Z-0719-2020 · Initiated November 21, 2019

    Recall

    Recall Number
    Z-0719-2020
    Event Number
    84376
    Firm
    3M Company Health Care Business 3m Center
    FEI Number
    2110898
    Product Code
    KGX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 21, 2019
    Terminated
    April 23, 2021
    Address
    2510 Conway Ave, B # 275-5-W-6, Saint Paul, MN, 55144-0001

    Description

    3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, 1590B-136

    Reason

    While the product meets all safety and efficacy criteria, long term exposure of 3M Durapore Advanced Surgical Tape to continuous high moisture clinical applications has not fully met all of 3M s performance expectations. This use environment may cause tape bond failure, leading the tape to not perform as intended. Further, the tape fibers may fray which could be accidentally ingested or aspirated.

    Action

    The firm initiated the recall by letter on 11/20/2019. The letter explained the failures seen and requested the following actions be taken: 1. Immediately cease use of the product and quarantine it for destruction/disposal. 2. Complete the attached Customer Acknowledgement Form with the following: - Acknowledge that you have read and understood this letter whether or not you have any 3M" Durapore" Advanced Surgical Tape in stock at your facility; and - Indicate if you have any product in stock and dispose of this material per facility policy. - Email the completed form to [email protected] 3. If there are clinical questions, contact Kimberly Schommer, RN, BSN via the 3M Health Care Customer Helpline at 1-800-228-3957.

    Distribution

    Nationwide, Canada, Germany, France, Switzerland, Denmark

    Quantity

    470,954 rolls