BEUDAMED
    FDA Enforcement Class II 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 · Reported January 1, 2020

    Enforcement

    Recall Number
    Z-0719-2020
    Event ID
    84376
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    3M Company - Health Care Business
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2020
    Initiation Date
    November 21, 2019
    Classification Date
    December 20, 2019
    Termination Date
    April 23, 2021
    Address
    3m Center 2510 Conway Ave , B# 275-5-W-6, Saint Paul, MN, 55144-0001, United States

    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.

    Code Info

    All lots

    Distribution

    Nationwide, Canada, Germany, France, Switzerland, Denmark

    Quantity

    470,954 rolls