Recall Z-0340-2007 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Medtronic Intersept Custom Tubing Pack. Do Not Reuse. The design and components of this product were specified by the user from an array of components and designs offered by the manufacturer. Any change in the cardiopulmonary bypass procedure that compromises the function of this Custom Tubing Pack is the responsibility of the user. The tubing is made of polyvinyl chloride (PVC). Portions of
| Date | Jan 25, 2007 (initiated Sep 13, 2006) |
| Status | Terminated |
| Reason | An out of specification condition exists with the tapered tubing found in some Custom Tubing Packs. The wall thickness is undersized and does not meet specifications. |
| Root cause | Other |
| Action | An Important Customer Notification, dated 09/06/06, was sent to affected customers. The letter identifies the affected model and lot numbers. Medtronic requests that affected product be returned. A suplemental pack can be built and shipped to the customer upon request. Medtronic will replace all returned product. A Recall Certificate is asked to be completed by customer and faxed to Medtronic. |
| Quantity | 146 |
| Distribution | Distributed in 6 states: CA, FL, IL, IN, LA and TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K800178 | EXTRACORP.'S INTERSEPT CUS. TUBING PK. Extracorporeal Medical Specialities, Inc., Feb 21, 1980 |