Recall Z-0268-2016 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The Tubing Pack design and components are specified by the user, they are packaged with consideration of setup efficiency and respect for the environment, and they are intended for use in the extracorporeal circuit during cardiopulmonary bypass procedures. Medtronic Tubing Packs can contain c
| Date | Oct 28, 2015 |
| Status | Terminated |
| Reason | This recall is being initiated due to a potential breach of the Tubing Pack Header Bags manufactured in these select lots. The seal in question is between the Tyvek and the Poly side of the header bag. |
| Root cause | Packaging process control |
| Action | Medtronic sent an Urgent Medical Device Recall letter dated October 2015 to all affected consignees. The letter described the problem and the product involved in the recall. Consignees were advised to quarantine and return all affected product and to complete and return the Customer Confirmation certificate. For questions contact your Medtronic representative or contact Medtronic's national Answering service at 800-633-8766. |
| Quantity | 496 |
| Distribution | Nationwide Distribution including US: AL, IL, IN, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012538 | TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE Medtronic Vascular, Aug 23, 2001 |