FDA Device recall Z-2495-2020
Extra corporeal circuit with bio-active surface
- FDA Device
- Class II
- terminated
- Published 2020-07-15
On 2020-07-15 the FDA classified a Class II recall of Extra corporeal circuit with bio-active surface by Medtronic Perfusion Systems, citing affected products failed a sterilization test.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2495-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-08 |
| Published | 2020-07-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Perfusion Systems |
| Distribution | CA, MI |
Product
Extra corporeal circuit with bio-active surface.
Reason
Affected products failed a sterilization test.
Identifiers
| code_info | Lot# 215729283 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2495-2020%22
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