Customed, Inc: Medical Device Recall in 2014 - (Recall #: Z-0240-2015)

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:

Wound Closure Tray I, Catalog number 900-063. 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-0240-2015

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: 66250

Code Information:

Lot numbers: 111112932 111123285 112010264 112030760 112041053 112051645 112062307 112083045 112093740 112104126 112114893 113025998 113046869 113078228 113078662 113099263 131110063 131210669 140111107 140211528 140412569 140412798 140613556 140714140 140815029

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated