Recall Z-2210-2012 ยท NCP
Maquet Inc.
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 info.cp@maquet.com www.maquet.com Used to introduce blood and sterile solution to the circulation system during extracorporeal circulation procedures
| Date | Aug 15, 2012 (initiated May 29, 2012) |
| Status | Terminated |
| Reason | Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip. |
| 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 |
| Quantity | 20 devices US; 122 devices foreign |
| Distribution | Worldwide Distribution - USA including MI, MN and Internationally |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023251 | PEDIATRIC ARTERIAL CANNULA Polystan A/S, Dec 4, 2002 |