Recall Z-1922-2008 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Medtronic AFFINITY NT Hollow Fiber Oxygenator with Plasma Resistant fiber with Carmeda BioActive Surface, Catalog Number: CB511, CB5201R14, and CB5227R4.
| Date | Jul 24, 2008 (initiated May 9, 2008) |
| Status | Terminated |
| Reason | 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). |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 147 US, 19 OUS |
| Distribution | Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000430 | AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511 Medtronic Vascular, Feb 25, 2000 |