BEUDAMED
    FDA Enforcement Class II Terminated

    Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size: 3in)

    Recall: Z-1204-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1204-2018
    Event ID
    79454
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Johnson & Johnson Consumer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 4, 2018
    Initiation Date
    December 18, 2017
    Classification Date
    March 27, 2018
    Termination Date
    April 14, 2020
    Address
    199 Grandview Rd, Skillman, NJ, 08558-1311, United States

    Description

    Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size: 3in)

    Reason

    Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in the U.S. of select COACH¿ Self-Adhering Sports Wraps, BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wraps and BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wraps products. The current labeling claim states not made with natural rubber latex which needs to be updated based upon recent awareness that natural latex was used as a base ingredient in the early-stage manufacturing process, which reduces the allergic protein found in natural latex.

    Code Info

    111615100 381371161515 103813711615120000

    Distribution

    Nationally