Recall Z-1572-2013 ยท FGY Cannula, Injection
Maquet Cardiovascular Us Sales, Llc
MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures.
| Date | Jun 21, 2013 (initiated May 14, 2013) |
| Status | Terminated |
| Reason | The specified part numbers and lot numbers of Maquet Pediatric Arterial Cannula Packs may contain an incorrectly sized connector. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.