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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 Device Recall CVS Pharmacy Plastic Sesame Street Adhesive Bandages see related information
Date Initiated by Firm February 21, 2011
Date Posted April 01, 2011
Recall Status1 Terminated 3 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 Egypt
Manufacturer Reason
for Recall		 The bandages are labeled as sterile, but failed sterility testing.
FDA Determined
Cause 2		 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 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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