FDA Device recall Z-1891-2021
Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, 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 CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, 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-1891-2021 |
| 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 CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
Reason
Specific lots may have been manufactured with insufficient or incomplete welds.
Identifiers
| code_info | GTIN 00763000499105, Lot numbers 221719701, Use By 2023-01-06; and 221764442, Use By 2023-01-13 |
|---|
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-1891-2021%22
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