Z-2210-2012 Class II Terminated
FDA device recall Z-2210-2012 was initiated by Maquet Inc. on May 29, 2012 and is designated Class II. Reason for recall: Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip. The recall status is terminated (terminated April 3, 2014). Affected quantity: 20 devices US; 122 devices foreign.
Recall Details
- Product Type
- Devices
- Report Date
- August 22, 2012
- Initiation Date
- May 29, 2012
- Termination Date
- April 3, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 devices US; 122 devices foreign
Product 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 info.cp@maquet.com www.maquet.com Used to introduce blood and sterile solution to the circulation system during extracorporeal circulation procedures
Reason for Recall
Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.
Distribution Pattern
Worldwide Distribution - USA including MI, MN and Internationally
Code Information
510k023251 US Catalog Number 161412 Batch Number 92048923 Foreign Catalog number 161412 Batch number 92048923 Catalog number 161412 Batch number 92051578