Recall Z-1227-2007 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Medtronic Intersept 3608 Sterile tubing (8') 1/2 x 3/32 in. Quantity 10, Lot 7626621, Use by 2009-07-31. Manufacturer: Medtronic, Inc. Minneapolis, MN 55432-5604 USA. Different components and tubing sets are included within the Custom Pack depending on customer requirements. Tubing sets are placed within a plastic tray, which then is wrapped and placed inside a header bag and sealed at t
| Date | Sep 25, 2007 (initiated Aug 1, 2007) |
| Status | Terminated |
| Reason | Medtronic Custom Tubing Packs might have open header bag seals. |
| Root cause | Other |
| Action | Certified letters dated 8/1/07 were sent to customers. The letter explains the situation and requests the impacted product to be returned to Medtronic for replacement or credit. The customers are being requested to complete a Recall Certificate acknowledging the receipt of the information. |
| Quantity | 853 packs |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |