Z-2210-2012Class II

Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt...

Name: Z-2210-2012 Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt...
Creator: Maquet Inc.
Published: 2012-05-29
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2012-05-29 / Terminated / root cause: design

FDA source

Maquet Inc. began a recall of 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... on 2012-05-29. FDA classified it as Class II and gives the reason as "Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2210-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-29
Posted: 2012-08-15
Terminated: 2014-04-03
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: 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
Product code: NCP
Reason for recall: Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.
Root cause tag: design
FDA root cause: Device Design
Action: Maquet issued Urgent Device 2, Recall letters/Urgent Product Recall Forms dated May 29, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their current stock and identify any affected product and remove from their inventory. Customers were instructed to contact the customer service department at 800-777-4222 (option #2, followed by option #2). Customers were also instructed to completed the enclsoed Recall Form to acknowledge receipt of the notification and to document the current status of the devices shipped to their facility. For questions regarding this recall call 973-709-7660.
Quantity in commerce: 20 devices US; 122 devices foreign
Distribution: Worldwide Distribution - USA including MI, MN and Internationally
Product codes and lots: 510k023251 US Catalog Number 161412 Batch Number 92048923 Foreign Catalog number 161412 Batch number 92048923 Catalog number 161412 Batch number 92051578

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2210-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2210-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-15

Product code NCP

K023251Class IIPediatric Arterial CannulaPolystan A/S / cleared 2002-12-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)