Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
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