Z-1875-2011
CVS Pharmacy Plastic Sesame Street Adhesive Bandages; a sterile, latex free, assorted sizes with multiple...
Pharmaplast S.A.E. / initiated 2011-02-21 / Terminated / root cause: manufacturing process
Pharmaplast S.A.E. began a recall of CVS Pharmacy Plastic Sesame Street Adhesive Bandages; a sterile, latex free, assorted sizes with multiple designs adhesive bandages; 20 bandages per box, 24... on . The reason FDA records is "The bandages are labeled as sterile, but failed sterility testing". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1875-2011
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Pharmaplast S.A.E.
- 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.
- Product code
- KGX Tape And Bandage, Adhesive
- Reason for recall
- The bandages are labeled as sterile, but failed sterility testing.
- Root cause tag
- manufacturing process
- FDA root cause
- 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.
- Product codes and lots
- REF CVS 826159, UPC 0 50428 95118 7, lot number 10J10
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