PERY GYN PACK CUSTOMED 10/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Code information: Code:9001091 Lots: 141015789 exp. 5/31/19 141115972 exp. 12/31/15 150116985 exp. 1/31/16 150217441 exp. 2/28/16 150217442 exp. 2/28/16 150418281 exp. 4/30/16 150518223 exp. 5/31/16 150519018 exp. 5/31/16

Distribution pattern: Distributed Only in Puerto Rico.