Medtronic AFFINITY NT Hollow Fiber Oxygenator with Carmeda BioActive Surface, CB511, with Plasma Resistant Fiber. Single
FDA device recall Z-1919-2008 · posted 2008-07-24 · Terminated
Recall details
- Recalling firm
- Medtronic Perfusion Systems
- Reason for recall
- Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin. Medtronic's heparin supplier recently reported that it had provided some batches to Medtronic that were contaminated with oversulfated chondroitin sulfate (OSCS).
- Action taken
- Medtronic issued a Press Release on 05/07/2008. An Urgent Medical Device Recall letter was sent to customers on May 07, 2008. The letter identifies affected devices, explains the situation and requests that the impacted product be returned to Medtronic for disposal. The end user will be requested to complete a Recall Certificate acknowledging the receipt of this information.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DTN
- Quantity affected
- 84 US, 14 OUS
- Distribution
- Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.
- Date initiated
- 2008-05-09
- Date posted
- 2008-07-24
- Date terminated
- 2012-05-08
- Location
- Brooklyn Park, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711 (K031700) | Medtronic Perfusion Systems | 2003-08-29 |