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
Recall
- Recall Number
- Z-2210-2012
- Event Number
- 62471
- Firm
- Maquet Inc.
- FEI Number
- 3008355164
- Product Code
- NCP
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- May 29, 2012
- Posted
- August 15, 2012
- Terminated
- April 3, 2014
- Address
- 45 Barbour Pond Drive, Wayne, NJ, 07470
Description
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
Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.
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.
Worldwide Distribution - USA including MI, MN and Internationally
20 devices US; 122 devices foreign