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.
FDA Recall Z-1875-2011 · Posted 2011-04-01
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Recalling FirmPharmaplast S.A.E.
Recall StatusTerminated
Product CodeKGX
Date Initiated2011-02-21
Date Terminated2011-08-25
Product Quantity5,336 cases
Reason for Recall
The bandages are labeled as sterile, but failed sterility testing.
Firm 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
Root Cause
Process control
Distribution Pattern
Nationwide Distribution - Including Illinois.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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