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
This recall has been terminated (originally issued August 15, 2012).
- Company
- Maquet Inc.
- Recall Initiated
- May 29, 2012
- Posted
- August 15, 2012
- Terminated
- April 3, 2014
- Recall Number
- Z-2210-2012
- Quantity
- 20 devices US; 122 devices foreign
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.
Distribution
Worldwide Distribution - USA including MI, MN and Internationally
Lot / Code Info
510k023251 US Catalog Number 161412 Batch Number 92048923 Foreign Catalog number 161412 Batch number 92048923 Catalog number 161412 Batch number 92051578
Root Cause
Device Design
Action Taken
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.