Recall Z-1875-2011 ยท KGX Tape And Bandage, Adhesive
Pharmaplast S.A.E.
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.
| Date | Apr 1, 2011 (initiated Feb 21, 2011) |
| Status | Terminated |
| Reason | The bandages are labeled as sterile, but failed sterility testing. |
| 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 | 5,336 cases |
| Distribution | Nationwide Distribution - Including Illinois. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.