CLASS II Device recall · Reported 3 Oct 2012 · FDA Enforcement Report

Irrigation Catheters recalled by Applied Medical Resources

Applied Medical Resources is recalling Irrigation Catheters (, distributed nationwide in the US. The recall was initiated on 9 Aug 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Numbers: Lot Numbers IRR-023-10F: 1158230. IRR-080-4F: 1156082, 1170185, 1164648. IRR-080-6F: 1158960.

Quantity recalled40,238 units for all products in Recall Event

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-2448-2012
FDA event ID: 63100
Recalling firm: Applied Medical Resources, Rancho Santa Margarita, CA
Classification: Class II
Status: Terminated
Recall initiated: 9 Aug 2012
FDA classified: 25 Sep 2012
Reported: 3 Oct 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Device type: Heart & Vascular Devices

Timeline

9 Aug 2012	Recall initiated by company
25 Sep 2012	Classified by FDA	+47 days
3 Oct 2012	Published in enforcement report	+8 days

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

Reason for recall

Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.

Product as listed by the FDA

Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IRR-023-10F,CATHETER IRRIGATION 10F 23CM; IRR-080-4F, CATHETER, IRRIGATION 4F 80CM; IRR-080-6F, CATHETER, IRRIGATION 6F 80CM. Irrigation Catheters are indicated for irrigation in the peripheral vascular system and biliary tree.

Where it was distributed

Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Germany, Ecuador, Estonia, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Italy, Republic of Korea, Libyan Arab Jamahiriya, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Taiwan, and South Africa.

Nationwide

Questions about this recall

Why was it recalled?

Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.

Which lots are affected?

Model Numbers: Lot Numbers IRR-023-10F: 1158230. IRR-080-4F: 1156082, 1170185, 1164648. IRR-080-6F: 1158960.

Where was it sold?

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

Other products in this recall event

2 other products · FDA event 63100

This product is part of a recall event; the main page for the event is Biliary Catheters recalled by Applied Medical Resources.

Reported	Class	Recall	Company	Reason	Where
3 Oct 2012	CLASS II	Biliary Catheters recalled by Applied Medical Resources	Applied Medical Resources	Particulate Matter	Nationwide
3 Oct 2012	CLASS II	Embolectomy Catheters recalled by Applied Medical Resources	Applied Medical Resources	Particulate Matter	Nationwide

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