Customed, Inc: Medical Device Recall in 2014 - (Recall #: Z-0244-2015)

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:

Uretheral Catheter Tray, Catalog number 900-278. 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-0244-2015

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: 50950

Code Information:

Lot numbers: 111113096 111123429 112020157 112020479 112030817 112041410 112051447 112062453 112072960 112083428 112093754 113067870 113068167 113088807 113099431 131110259 131210687 140111124 140211538 140412668 140613604 140714264 140814790 140915160

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated