Customed, Inc: Medical Device Recall in 2016 - (Recall #: Z-1465-2016)

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: 9003190 SURG GOWN SMS AMMI IV FULL 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-1465-2016

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: 96

Code Information:

LOTS: SL15195-02 (150619269) 31-JUL-16 SL15251 (150820570) 31-AUG-16

Distribution Pattern:

Distributed only in Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated