Customed, Inc: Medical Device Recall in 2016 - (Recall #: Z-1435-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Catalog Number: 900176 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Product Classification:

Class II

Date Initiated: January 7, 2016

Date Posted: April 20, 2016

Recall Number: Z-1435-2016

Event ID: 72992

Reason for Recall:

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

Status: Terminated

Product Quantity: 938

Code Information:

LOTS: SL15170 (150619367) 30-JUN-16 SL15170 (150619366) 30-JUN-16 SL15170 (150619364) 30-JUN-16 SL15170 (150619365) 30-JUN-16 SL15187 (150719668) 31-JUL-16 SL15191-01 (150719669) 31-JUL-16 SL15191-01 (150719670) 31-JUL-16 SL15191-01 (150719667) 31-JUL-16 SL15211 (150720120) 31-JUL-16 SL15211 (150720142) 31-JUL-16 SL15211 (150720122) 31-JUL-16 SL15212 (150720143) 31-JUL-16 SL15212 (150720142) 31-JUL-16 SL15212 (150720121) 31-JUL-16 SL15215 (150720122) 31-JUL-16 SL15215 (150720141) 31-JUL-16 SL15215 (150720121) 31-JUL-16 SL15222 (150720120) 31-JUL-16 SL15233 (150820566) 31-AUG-16 SL15233 (150820568) 31-AUG-16 SL15240 (150820569) 31-AUG-16 SL15243 (150820567) 31-AUG-16 SL15243 (150820566) 31-AUG-16 SL15245 (150820698) 31-AUG-16 SL15245 (150820697) 31-AUG-16 SL15245 (150820696) 31-AUG-16

Distribution Pattern:

Distributed only in Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated