Customed, Inc: Medical Device Recall in 2014 - (Recall #: Z-0246-2015)

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 Gown Poly Reinforced Lgc, Catalog number 900-522. 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-0246-2015

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: 86912

Code Information:

Lot numbers: 111103265 111113126 112010183 112020505 112030804 112041056 112051993 112072804 112093631 112104361 112104533 112124897 113026196 113036804 113057491 113067873 113078333 113088873 113099438 113109852 131110265 131210654 140111126 140211540 140312173 140312384 140513370 140714295 140814813 140814957 140915481

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated