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 components with Carmeda BioActive Surface, Trillium BioSurface, Balance BioSurface or no coating. Sterile barrier for these packs is provided either by a Tyvek lid seal on the tray or by a header bag.
This recall has been terminated (originally issued October 28, 2015).
- Company
- Medtronic Perfusion Systems
- Recall Initiated
- October 28, 2015
- Terminated
- August 17, 2016
- Recall Number
- Z-0268-2016
- Quantity
- 496
- Firm Location
- Brooklyn Park, MN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide Distribution including US: AL, IL, IN, and WI.
Lot / Code Info
Model Lot Numbers Lot Number HY2W85R9 209704344,209704345,209704346, 209704347,210010558 TL7M64R3 209789393 TL7P17R1 209789333
Root Cause
Packaging process control
Action Taken
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.