Class 2 Device Recall Carepak

• Date Initiated by Firm: June 10, 2015
• Date Posted: August 25, 2015
• Recall Status: Terminated on October 12, 2016
• Recall Number: Z-2460-2015
• Recall Event ID: 71682
• Product Classification: Tape and bandage, adhesive - Product Code KGX
• Product: Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes
• Code Information: Model #141168; Lots #s 00013359, 00020722 and 00028721.
• FEI Number: 1038758
• Recalling Firm/ Manufacturer: ASO, LLC; 300 Sarasota Center Blvd; Sarasota FL 34240-9381
• For Additional Information Contact: Federico Juliao; 941-379-0300 Ext. 1187
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Process control
• Action: Customers were contacted by phone and e-mail on 06/10/2015; First class letter was sent on 06/23/2015.
• Quantity in Commerce: 655 cases.
• Distribution: US Distribution to Rhode Island only
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.