Customed, Inc: Medical Device Recall in 2015 - (Recall #: Z-2644-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

GOWN COOL IMPEV. XLGE BREATHABLE 24/CS CUSTOMED 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: July 10, 2015

Date Posted: September 9, 2015

Recall Number: Z-2644-2015

Event ID: 71721

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: 216

Code Information:

Code:9002592 Lots: 140915320 exp. 9/30/19 150116795 exp. 3/31/16 150217395 exp. 3/31/16 150317646 exp. 3/31/16 150317849 exp. 5/31/16 150317850 exp. 5/31/16 150317848 exp. 5/31/16 150418378 exp. 6/30/16

Distribution Pattern:

Distributed Only in Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated