Customed, Inc: Medical Device Recall in 2014 - (Recall #: Z-0241-2015)

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 II, Catalog number 900-064. 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-0241-2015

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: 12300

Code Information:

Lot numbers: 111112975 112020298 112030800 112062308 131010025 131210852 140211529 140513036 140714141

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated