MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures.
FDA Recall Z-1572-2013 · Posted 2013-06-21
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Recalling FirmMaquet Cardiovascular Us Sales, Llc
Recall StatusTerminated
Product CodeFGY
Date Initiated2013-05-14
Date Terminated2014-09-18
Product Quantity100 units (60 Domestic; 40 International)
Reason for Recall
The specified part numbers and lot numbers of Maquet Pediatric Arterial Cannula Packs may contain an incorrectly sized connector.
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
Worldwide Distribution - US Distribution including the states of Delaware, Illinois, Minnesota , New York., Ohio and Pennsylvania and the countries of Germany, Turkey and France.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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