Device product
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
Z-2210-2012
Product summary
- Firm
- Maquet Inc.
- Event
- Event 62471
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 devices US; 122 devices foreign
- Official record key
device-enforcement:Z-2210-2012
Official wording
Reason: Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.
Code information: 510k023251 US Catalog Number 161412 Batch Number 92048923 Foreign Catalog number 161412 Batch number 92048923 Catalog number 161412 Batch number 92051578
Distribution pattern: Worldwide Distribution - USA including MI, MN and Internationally
Derived failure modes
-
Unknown
Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.