Recall Z-2210-2012— Maquet Inc.
Class II · Terminated
Class II FDA medical device recall by Maquet Inc., initiated 2012-05-29, terminated 2014-04-03. It names one FDA 510(k) clearance: K023251. 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. Reason: Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip..
- Recalling firm
- Maquet Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-05-29
- Terminated
- 2014-04-03
- Firm location
- Wayne, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.