Recall Z-0476-2008 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Medtronic Trillium Affinity NT, 541T, Integrated CVR/Membrane Oxygenator (Plasma Resistant Fiber [PRF] Medtronic, Inc., Minneapolis, MN 55432-5604.
| Date | Jan 26, 2008 (initiated Oct 1, 2007) |
| Status | Terminated |
| Reason | Unnaproved Component Resin: Affinity NT Integrated CVR Membrane Oxygenators and EL 240 Autotransfusion Blood Collection Reservoirs contain components made from an unapproved resin |
| Root cause | Nonconforming Material/Component |
| Action | Medtronic sales force was notified and initiated calls with cutomers on 10/1/07. Additionally, certified Urgent Medical Device Recall letters dated 10/5/2007, were sent to the 32 customers. The letter explained the situaiton and requested that the impacted product be returned for replacement or credit. Medtronic is assessing patient use risks and will report those when determined. Standard post-surgical monitoring is advised at the present by Medtronic . |
| Quantity | 34 |
| Distribution | Nationwide including the states of IL, CT, OK, OH, MN, FL, NY, KS, MO, LA, PA, IN, CA, MI, KY, SC, NE, and AR. |
| FDA record | Open on fda.gov |