FDA Recall Terminated

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.

Recall: Z-1875-2011 · Initiated February 21, 2011

Recall

Recall Number
Z-1875-2011
Event Number
58051
Firm
Pharmaplast S.A.E. Free Zone Factory POB 37 Amria Free Zone Kafr El Zayat, Gharbia Egypt
FEI Number
3003767891
Product Code
KGX
Status
Terminated
Root Cause
Process control
Initiated
February 21, 2011
Posted
April 1, 2011
Terminated
August 25, 2011

Description

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.

Reason

The bandages are labeled as sterile, but failed sterility testing.

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

Distribution

Nationwide Distribution - Including Illinois.

Quantity

5,336 cases