Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt Germany Phone +
FDA device recall Z-2210-2012 · posted 2012-08-15 · Terminated
Recall details
- Recalling firm
- Maquet Inc.
- Reason for recall
- Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NCP
- Quantity affected
- 20 devices US; 122 devices foreign
- Distribution
- Worldwide Distribution - USA including MI, MN and Internationally
- Date initiated
- 2012-05-29
- Date posted
- 2012-08-15
- Date terminated
- 2014-04-03
- Location
- Wayne, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PEDIATRIC ARTERIAL CANNULA (K023251) | Polystan A/S | 2002-12-04 |