CLASS I Device recall · Reported 10 Dec 2014 · FDA Enforcement Report

Uretheral Catheter Tray recalled by Customed

Customed is recalling Uretheral Catheter Tray, distributed in Florida, New York, Puerto Rico. The recall was initiated on 8 Oct 2014 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot numbers: 111113096 111123429 112020157 112020479 112030817 112041410 112051447 112062453 112072960 112083428 112093754 113067870 113068167 113088807 113099431 131110259 131210687 140111124 140211538 140412668 140613604 140714264 140814790 140915160

Quantity recalled50950

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0244-2015
FDA event ID: 69448
Recalling firm: Customed, Fajardo, PR
Classification: Class I
Status: Terminated
Recall initiated: 8 Oct 2014
FDA classified: 28 Nov 2014
Reported: 10 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

8 Oct 2014	Recall initiated by company
28 Nov 2014	Classified by FDA	+51 days
10 Dec 2014	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Uretheral Catheter Tray, Catalog number 900-278. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Where it was distributed

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

Florida New York Puerto Rico

Stores named: Walmart

Questions about this recall

Is Uretheral Catheter Tray recalled?

Yes. Customed recalled Uretheral Catheter Tray on 8 Oct 2014. The recall is Class I and its status is Terminated. Recall number Z-0244-2015.

Why was it recalled?

Which lots are affected?

Lot numbers: 111113096 111123429 112020157 112020479 112030817 112041410 112051447 112062453 112072960 112083428 112093754 113067870 113068167 113088807 113099431 131110259 131210687 140111124 140211538 140412668 140613604 140714264 140814790 140915160

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Customed

All 682

Reported	Class	Recall	Company	Reason	Where
20 Apr 2016Device	CLASS II	Catalog Number: 900277 Suction Catheter Tray 14FR With Sodium recalled	Customed	Sterility	PR
20 Apr 2016Device	CLASS II	Catalog Number: 9002940 Obstetrical Surgical Pack Used by medical recalled	Customed	Sterility	PR
20 Apr 2016Device	CLASS II	Catalog Number: 900010 Suture Removal KIT Used by medical staff to recalled	Customed	Sterility	PR
20 Apr 2016Device	CLASS II	Catalog Number: 9001933 Ophtalmic Surgical Pack Used recalled	Customed	Sterility	PR
20 Apr 2016Device	CLASS II	Catalog Number: 900169 Universal Surgical Pack Used by medical staff recalled	Customed	Sterility	PR

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