FDA Device recall Z-1892-2021
Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, 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 BB8M63R5, Custom Pack BB8M63R5 Adult ECC, 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-1892-2021 |
| 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 BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
Reason
Specific lots may have been manufactured with insufficient or incomplete welds.
Identifiers
| code_info | GTIN 00763000458133, Lot number 221249911, Use By 2022-10-22 |
|---|
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-1892-2021%22
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