Recall Z-0808-05 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Medtronic Custom Packs and Total System Packs. Pack can contain a number of different components specified by the customer and individualized for their bypass circuit set up requirements. Intersept Custom Tubing Pack, Sterile and nonpyrogenic Fluid Path: Do not use if package is opened or damaged. For Single Use Only. Manufacturer: Medtronic , Inc. Minneapolis, MN 55432-5604 USA
| Date | May 10, 2005 (initiated Mar 25, 2005) |
| Status | Terminated |
| Reason | Some warehouse inventory of Custom Pack product bags were found with ruptured seals. The seals were partially opened in the center of the bag's Tyvek edge. Since this bag is used to enclose and seal the custom pack assembly & had been sterilized, the ruptured seal breaches the sterility barrier for the package. |
| Root cause | Other |
| Action | US customers were sent certified letters beginning 03/25/05 identifying the situation, cautioning customers about the possibility of an open bag with loss of sterility and requested return of all product to Medtronic Perfusions Systems at 7611 Northland Blvd., Brooklyn Park, MN. Customers are also requested to complete a Field Corrective Action Certificate acknowledging the receipt of this information. |
| Distribution | nationwide, Canada, Australia, Japan and Latin America |
| FDA record | Open on fda.gov |