BEUDAMED
    FDA Recall Terminated

    Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes

    Recall: Z-2460-2015 · Initiated June 10, 2015

    Recall

    Recall Number
    Z-2460-2015
    Event Number
    71682
    Firm
    ASO, LLC
    FEI Number
    1038758
    Product Code
    KGX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 10, 2015
    Posted
    August 25, 2015
    Terminated
    October 12, 2016
    Address
    300 Sarasota Center Blvd, Sarasota, FL, 34240-9381

    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.

    Action

    Customers were contacted by phone and e-mail on 06/10/2015; First class letter was sent on 06/23/2015.

    Distribution

    US Distribution to Rhode Island only

    Quantity

    655 cases.