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U.S. Department of Health and Human Services

Class 2 Device Recall Carepak

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  Class 2 Device Recall Carepak see related information
Date Initiated by Firm June 10, 2015
Date Posted August 25, 2015
Recall Status1 Terminated 3 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.
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 2		 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.
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