BEUDAMED
    FDA Enforcement Class II Terminated

    Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes

    Recall: Z-2460-2015 · Reported September 2, 2015

    Enforcement

    Recall Number
    Z-2460-2015
    Event ID
    71682
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ASO, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 2, 2015
    Initiation Date
    June 10, 2015
    Classification Date
    August 25, 2015
    Termination Date
    October 12, 2016
    Address
    300 Sarasota Center Blvd, N/A, Sarasota, FL, 34240-9381, United States

    Description

    Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes

    Reason

    Contain 0.1% Benzalkonium Chloride in the 5/8 bandages inside the assortment which is not listed as an active ingredient in the product label.

    Code Info

    Model #141168; Lots #s 00013359, 00020722 and 00028721.

    Distribution

    US Distribution to Rhode Island only

    Quantity

    655 cases.