FDA Device recall Z-1883-2021
Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System
- FDA Device
- Class II
- terminated
- Published 2021-06-23
On 2021-06-23 the FDA classified a Class II recall of Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System 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-1883-2021 |
| 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 HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
Reason
Specific lots may have been manufactured with insufficient or incomplete welds.
Identifiers
| code_info | GTIN 00763000467449, Lot number 221227814, Use By 2022-08-28 |
|---|
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-1883-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.