Customed, Inc: Medical Device Recall in 2014 - (Recall #: Z-0237-2015)

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:

Surgical packs (includes trays, bags and kits) 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-0237-2015

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 (QSR) and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Status: Terminated

Product Quantity: 185000

Code Information:

Lot numbers 111102811 111112953 111112969 111123257 111123438 112010003 112020291 112030762 112041051 112041384 112051641 112051718 112062298 112072758 112083040 112104122 112104289 112114540 112124364 112124885 113025838 113026102 113026206 113057390 113057682 113099556 131010023 131210663 140111103 140412874 140513047 140513388 140613946 140714499 140815022

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated