Customed, Inc: Medical Device Recall in 2014 - (Recall #: Z-0245-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Surgeon Reinforced Gown XL, Catalog number 900-521. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Product Classification:

Class I

Date Initiated: October 8, 2014

Date Posted: December 10, 2014

Recall Number: Z-0245-2015

Event ID: 69448

Reason for Recall:

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Status: Terminated

Product Quantity: 89284

Code Information:

Lot numbers: 111103264 112010182 112020504 112030803 112041055 112051992 112062557 112062558 112072803 112093630 112104254 112104360 112114532 112114896 112125100 113026195 113036464 113036803 113057608 113057848 113068173 113088872 113089076 113109851 131210264 131210653 140111125 140211539 140312172 140312383 140513369 140714294 140714515 140814956 140915480

Distribution Pattern:

US Distribution to Florida, New York and Puerto Rico..

Voluntary or Mandated:

Voluntary: Firm initiated