Medtronic Perfusion Tubing Packs — Class II medical device recall Z-0268-2016
Terminated recall by Medtronic Perfusion Systems, reported 2015-11-18, distributed nationwide. This recall is being initiated due to a potential breach of the Tubing Pack Header Bags manufactured in these
| Recall number | Z-0268-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Perfusion Systems, Brooklyn Park, MN, United States |
| Recall initiated | 2015-10-28 |
| Classified | 2015-11-12 |
| Reported by FDA | 2015-11-18 |
| Terminated | 2016-08-17 |
| Distributed | Nationwide (US) |
| Quantity | 496 |
| Reason classes | packaging |
| Lot numbers | 209704344, 209704345, 209704346, 209704347, 209789333, 209789393, 210010558, HY2W85R9, TL7M64R3, TL7P17R1 |
| Model numbers | 209704344, 209704345, 209704346, 209704347, 209789333, 209789393, 210010558, HY2W85R9, TL7M64R3, TL7P17R1 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0268-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.