Customed, Inc: Medical Device Recall in 2016 - (Recall #: Z-1403-2016)

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: 900036 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-1403-2016

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: 132

Code Information:

LOTS: SL15170 (150418257) 30-APR-16 SL15170 (150418258) 30-APR-16 SL15181 (150619549) 30-JUN-16 SL15181 (150619548) 30-JUN-16 SL15199 (150719611) 31-JUL-16 SL15215 (150719612) 31-JUL-16 SL15216 (150719612) 31-JUL-16

Distribution Pattern:

Distributed only in Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated