Recall Z-0583-2007 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Medtronic 2T10R1 Intersept Custom Tubing Pack. Pack 2T10R1 consists of two PVC lines; one of them is 132 inch in length and is capped. The second line is 102 inch in length and has a one way vacuum relief valve assembled in one end. Tubing is used in the vent roller heads of the heart lung machine. This tubing is connected to the cannula in the patient in order to divert blood to the circuit
| Date | Mar 8, 2007 (initiated Jan 2, 2007) |
| Status | Terminated |
| Reason | One lot of Custom Perfusion Sets, Catalog 2T10R1 was incorrectly assembled. The one way vacuum relief valve on the 102 inch line is attached backwards, thus preventing flow. |
| Root cause | Other |
| Action | There was only one customer. The customer was sent a letter on December 29, 2006, requesting that the impacted product be disposed of or returned to Medtronic for disposal. |
| Quantity | 17 |
| Distribution | Illinois |
| FDA record | Open on fda.gov |