FDA Device recall Z-1365-2015
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only
- FDA Device
- Class II
- terminated
- Published 2015-04-08
On 2015-04-08 the FDA classified a Class II recall of Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only by Medtronic Cardiac Rhythm Disease Management, citing medtronic is conducting a voluntary recall of all former Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems due to potential for a sterility breach of the outer packagin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1365-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-23 |
| Published | 2015-04-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Cardiac Rhythm Disease Management |
| Distribution | US |
Product
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Reason
Medtronic is conducting a voluntary recall of all former Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems due to potential for a sterility breach of the outer packaging or pouch material. A breach of the outer pouch may compromise the outside surface sterility of the inner pouch and does not directly affect the sterility of the device components within the inner pouch.
Identifiers
| code_info | Model Lot Number" BVT608010 551902 BVT608010 551975 BVT608010 552014 BVT608030 551796…Model Lot Number" BVT608010 551902 BVT608010 551975 BVT608010 552014 BVT608030 551796 BVT608030 551873 BVT608030 551893 BVT608030 551923 BVT608030 552011 BVT608030 552097 BVT612010 551789 BVT612010 551837 BVT612010 551894 BVT612010 551974 BVT612010 551976 BVT612010 552030 BVT612010 552226 BVT612030 551808 BVT612030 551903 BVT612030 551904 BVT612030 551924 BVT612030 551980 BVT612030 552007 BVT612030 552017 BVT612030 552034 BVT612030 552071 BVT612030 552081 BVT612030 552229 BVT808015 551466 BVT808015 551797 BVT808015 551804 BVT808015 551895 BVT808015 551942 BVT808015 551950 BVT808015 551984 BVT808015 552020 BVT808015 552027 BVT808015 552067 BVT808015 552113 BVT808030 551436 BVT808030 551437 BVT808030 551464 BVT808030 551798 BVT808030 551803 BVT808030 551812 BVT808030 551841 BVT808030 551863 BVT808030 551897 BVT808030 551899 BVT808030 551922 BVT808030 551943 BVT808030 551947 BVT808030 551977 BVT808030 55198 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1365-2015%22
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