Customed, Inc: Medical Device Recall in 2014 - (Recall #: Z-0256-2015)

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:

Minor Laceration Tray, Catalog number 900-1765. 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-0256-2015

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: 66200

Code Information:

Lot numbers: 111113039 111123389 112010093 112020412 112030646 112041203 112051652 112051882 112062451 112062568 112093753 112114887 113036455 113047208 113057433 113057863 113078277 113088761 113099393 113109754 131110201 131210683 131210763 140111120 140312090 140512615 140513043 140613601 140613631 1121114534

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated