CLASS II Device recall · Reported 9 Sep 2015 · FDA Enforcement Report

Urology PK 5/CS Used by medical staff to perform surgical recalled

Customed is recalling Urology PK 5/CS Used by medical staff to perform surgical procedures and patient care, distributed in Puerto Rico. The recall was initiated on 10 Jul 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCode:9001738 Lots: 141015743 exp. 11/30/15 141216418 exp. 12/31/15 150317635 exp. 3/31/16 150318109 exp. 3/31/16

Quantity recalled10

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-2607-2015
FDA event ID: 71721
Recalling firm: Customed, Fajardo, PR
Classification: Class II
Status: Terminated
Recall initiated: 10 Jul 2015
FDA classified: 3 Sep 2015
Reported: 9 Sep 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

10 Jul 2015	Recall initiated by company
3 Sep 2015	Classified by FDA	+55 days
9 Sep 2015	Published in enforcement report	+6 days

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

Reason for recall

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

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

UROLOGY PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Where it was distributed

Distributed Only in Puerto Rico.

Puerto Rico

Stores named: Walmart

Questions about this recall

Is Urology PK 5/CS Used by medical staff to perform surgical procedures and patient care recalled?

Yes. Customed recalled Urology PK 5/CS Used by medical staff to perform surgical procedures and patient care on 10 Jul 2015. The recall is Class II and its status is Terminated. Recall number Z-2607-2015.

Why was it recalled?

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Which lots are affected?

Code:9001738 Lots: 141015743 exp. 11/30/15 141216418 exp. 12/31/15 150317635 exp. 3/31/16 150318109 exp. 3/31/16

Where was it sold?

Distributed Only in 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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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.

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