Z-1572-2013Class II

MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic...

Name: Z-1572-2013 MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic...
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2013-05-14
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2013-05-14 / Terminated / root cause: packaging

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal... on 2013-05-14. FDA classified it as Class II and gives the reason as "The specified part numbers and lot numbers of Maquet Pediatric Arterial Cannula Packs may contain an incorrectly sized connector". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1572-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-14
Posted: 2013-06-21
Terminated: 2014-09-18
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures.
Product code: FGY Cannula, Injection
Reason for recall: The specified part numbers and lot numbers of Maquet Pediatric Arterial Cannula Packs may contain an incorrectly sized connector.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Maquet sent an "Urgent Product Recall"/"Recall - Device Corrective Action Response" forms dated May 14, 2013, via Federal Express to all affected customers. The notification identifies affected product; informs customers of the nature of the issue; advises of potential adverse patient consequences that may occur; and advises customers to follow instructions on the "Recall-Device Corrective Action Response" forms included as part of the notification. If you have any further questions please contact your local MAQUET representative or call Customer Service at (888) 627-8383.
Quantity in commerce: 100 units (60 Domestic; 40 International)
Distribution: Worldwide Distribution - US Distribution including the states of Delaware, Illinois, Minnesota , New York., Ohio and Pennsylvania and the countries of Germany, Turkey and France.
Product codes and lots: Catalogue Number:Part Number: Lot Number are as follows: (1) 161410 (10 FR.):701022682:92056588 (2) 163610 (10 Fr):70102597:92059789 (3) 163608 (8 Fr.):70102.2681:92065640 (4) 163606 (6 Fr.):70102.2680:92063566

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1572-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1572-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-21

Product code FGY

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)