FDA Device recall Z-1874-2021
Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx
- FDA Device
- Class II
- terminated
- Published 2021-06-23
On 2021-06-23 the FDA classified a Class II recall of Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx by Medtronic Perfusion Systems, citing specific lots may have been manufactured with insufficient or incomplete welds.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1874-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-29 |
| Published | 2021-06-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Perfusion Systems |
| Distribution | US |
Product
Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
Reason
Specific lots may have been manufactured with insufficient or incomplete welds.
Identifiers
| code_info | GTIN 20763000446516, Lot numbers 22128923, Use By 2022-10-31; and Lot 221815851, Use By 2023-01-18 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1874-2021%22
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