CLASS II Device recall · Reported 22 Aug 2012 · FDA Enforcement Report

Getinge Group Pediatric Arterial Cannula Maquet recalled

Maquet is recalling Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe, distributed nationwide in the US. The recall was initiated on 29 May 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes510k023251 US Catalog Number 161412 Batch Number 92048923 Foreign Catalog number 161412 Batch number 92048923 Catalog number 161412 Batch number 92051578

Quantity recalled20 devices US; 122 devices foreign

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-2210-2012
FDA event ID: 62471
Recalling firm: Maquet, Wayne, NJ
Classification: Class II
Status: Terminated
Recall initiated: 29 May 2012
FDA classified: 15 Aug 2012
Reported: 22 Aug 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

29 May 2012	Recall initiated by company
15 Aug 2012	Classified by FDA	+78 days
22 Aug 2012	Published in enforcement report	+7 days

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

Reason for recall

Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.

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

Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt Germany Phone +49 7222 932-0 Fax: +49 7222 932-1888 [email protected] www.maquet.com Used to introduce blood and sterile solution to the circulation system during extracorporeal circulation procedures

Where it was distributed

Worldwide Distribution - USA including MI, MN and Internationally

Nationwide Michigan Minnesota

Questions about this recall

Is Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 recalled?

Yes. Maquet recalled Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 on 29 May 2012. The recall is Class II and its status is Terminated. Recall number Z-2210-2012.

Why was it recalled?

Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.

Which lots are affected?

510k023251 US Catalog Number 161412 Batch Number 92048923 Foreign Catalog number 161412 Batch number 92048923 Catalog number 161412 Batch number 92051578

Where was it sold?

Worldwide Distribution - USA including MI, MN and Internationally

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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