Recall Z-1110-2007 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Medtronic Intersept Filtered Cardiotomy Reservoir, Model 1351, Non-pyrogenic, Sterile, Manufacturer: Medtronic, Inc., Minneapolis, MN
| Date | Jul 26, 2007 (initiated Apr 18, 2007) |
| Status | Terminated |
| Reason | Pyrogen Levels detected above specification: The product contains a pyrogen level above Medtronic''s internal specifications while the product is labeled as nonpyrogenic. |
| Root cause | Other |
| Action | The consignees were notified by personal contact and requested to stop using the devices in question. A customer letter (April 24, 2007) will be sent by e-mail which explains the situation and requests that the impacted product be returned to Medtronic for disposal. The customer will be requested to complete a Recall Certificate acknowledging the receipt of this information. |
| Quantity | 11 units |
| Distribution | Nationwide: Distributed to states of CO and PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K926226 | INTERSEPT FILTERED CARDIOTOMY RESERVOIR Medtronic Vascular, Jun 22, 1993 |