Customed, Inc: Medical Device Recall in 2014 - (Recall #: Z-0242-2015)

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:

Tracheotomy Care Kit, Catalog number 900-110. 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-0242-2015

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: 78600

Code Information:

Lot numbers: 111102823 111112980 111123314 111123440 112020308 112020361 112030826 112041369 112041434 112051646 112062317 112083160 112093741 112104363 112124894 113015487 113035832 113046996 113047144 113057604 113057810 113078456 113078674 113089014 113109706 131110154 131110288 131210677 140111108 140211531 140312046 140412578 140513065 140613570 140714155 140714430 140814942

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated