Customed, Inc: Medical Device Recall in 2014 - (Recall #: Z-0238-2015)

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:

Irrigation Tray With Bulb Syringe, Catalog number 900-020. 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-0238-2015

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: 76800

Code Information:

Lot numbers: 111112971 111123273 112010006 112020294 112030797 112041052 112041386 112041450 112051644 112062300 112083043 112093635 113025799 113025979 113026274 113036446 113046993 113047330 113057829 113068135 113078452 113078659 113099261 131110143 140111104 140211714 140312032 140412568 140513034 140613550 140814606 140815025

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated