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U.S. Department of Health and Human Services

Class 2 Device Recall CVS Pharmacy Plastic Sesame Street Adhesive Bandages

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 Class 2 Recall
CVS Pharmacy Plastic Sesame Street Adhesive Bandages
see related information
Date Posted April 01, 2011
Recall Status1 Terminated on August 25, 2011
Recall Number Z-1875-2011
Recall Event ID 58051
Product Classification Tape And Bandage, Adhesive - Product Code KGX
Product CVS Pharmacy Plastic Sesame Street Adhesive Bandages; a sterile, latex free, assorted sizes with multiple designs adhesive bandages; 20 bandages per box, 24 boxes per case; Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in Egypt; REF CVS 826159, UPC 0 50428 95118 7 The device is used to cover and protect wounds.
Code Information REF CVS 826159, UPC 0 50428 95118 7, lot number 10J10
Recalling Firm/
Manufacturer
Pharmaplast S.A.E.
Free Zone Factory POB 37
Amria Free Zone
Kafr El Zayat, Gharbia
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
The bandages are labeled as sterile, but failed sterility testing.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Pharmaplast S.A.E. called the direct account on 2/17/11 and sent a Urgent Medical device recall letter dated 2/21/11 to the direct account via overnight mail, requesting that they examine their inventory for the non-sterile adhesive bandages and quarantine them for return to Pharmaplast via sea freight. The account was instructed to contact their customers concerning the recall and return their stocks of the affected lot, which was done by telephone calls on 2/17/11. For questions regarding this Recall please call 00203-4500264.
Quantity in Commerce 5,336 cases
Distribution Nationwide Distribution - Including Illinois.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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