PREMIUM LAPAROTOMY PK CUSTOMED 6/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:9001296 Lots: 140915095 exp. 2/28/19 141115975 exp. 11/30/15 150116734 exp. 1/31/16 150116736 exp. 2/28/16 150116737 exp. 2/28/16 150116739 exp. 2/28/16 150116738 exp. 2/28/16 150116735 exp. 2/28/16 150217232 exp. 2/28/16 150217230 exp. 2/28/16 150217233 exp. 2/28/16 150217234 exp. 3/31/16 150217235 exp. 3/31/16 150217231 exp. 3/31/16 150317683 exp. 3/31/16 150317684 exp. 3/31/16 150317685 exp. 3/31/16 150317686 exp. 4/30/16 150317687 exp. 4/30/16 150418285 exp. 4/30/16 150418286 exp. 4/30/16 150418287 exp. 4/30/16 150418288 exp. 4/30/16 150418289 exp. 4/30/16 150518634 exp. 5/31/16 150518635 exp. 5/31/16 150519022 exp. 5/31/16 150519023 exp. 5/31/16

Distribution pattern: Distributed Only in Puerto Rico.