Customed, Inc: Medical Device Recall in 2016 - (Recall #: Z-1475-2016)

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: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE 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-1475-2016

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: 1148

Code Information:

LOTS: SL15174 (150518822) 31-MAY-16 SL15176 (150317997) 31-MAR-16 SV15168 (150418241) 30-APR-16 SV15168 (150117022) 31-MAR-16 SL15180 (150418241) 30-APR-16 SL15209 (150720052) 31-JUL-16 SL15210 (150720052) 31-JUL-16 SL15218 (150720052) 31-JUL-16 SL15219 (150720052) 31-JUL-16 SL15222 (150720052) 31-JUL-16 SL15246 (150820337) 31-AUG-16 SL15251 (150820337) 31-AUG-16 SL15252 (150820337) 31-AUG-16

Distribution Pattern:

Distributed only in Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated