Recall Z-2005-2008 ยท DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Medtronic International Trade Inc
Medtronic Trillium AFFINITY NT, 511T, Hollow Fiber Oxygenator with Trillium Biopassive Surface, with Plasma Resistant Fiber. MODEL Numbers: 95215, 95216, 95217, 95249, 95250, 95252, 0H46R28, 0M81R41, 0R35R13, 0Y95R22, 1702R51, 1A11R16, 1A19R26, 1B22R5, 1F66R12, 1G47R4, 1K86R3, 1K93R5, 1L71R20, 1M05R12, 1P07R6, 1X24R, 2892R18, 2D64R12, 2E55R9, 2N90R8, 2V85R4, 3B89R12, 3C98R7, 3P11R4, 3R39R2, 3R4
| Date | Jul 30, 2008 (initiated May 7, 2008) |
| Status | Terminated |
| Reason | Medtronic is advising that certain Trillium-coated Medtronic cardiopulmonary bypass (CBP) products (e.g., oxygenators, reservoirs, pumps and tubing packs) were manufactured with heparin batches contaminated with oversulfated chondroitin sulfate (OSCS). Based upon currently available information, Medtronic has determined that Medtronic Trillium-coated products can continue to be used in cardiopulm |
| Root cause | Nonconforming Material/Component |
| Action | Medtronic Cardiovascular Customers were sent the May 05, 2008 Urgent Medical Device Corrective Action letter to advise them that certain Trillium-coated cardiopulmonary bypass products were manufactured with heparin which may be contaminated with oversulfated chondroitin sulfate. The letter discussed the risk evaluation and gave recommendations to healthcare professionals for patient care. Affected devices can continue to be used in cardiopulmonary bypass procedures. |
| Quantity | 59500 |
| Distribution | Worldwide Distribution, including USA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.