FDA Device recall Z-0124-2025
MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840
- FDA Device
- Class II
- ongoing
- Published 2024-10-23
On 2024-10-23 the FDA classified a Class II recall of MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840 by Medline Industries Northfield, citing medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, produc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0124-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-28 |
| Published | 2024-10-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840
Reason
Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.
Identifiers
| code_info | UDI/DI 40195327185078 (case), 10195327185077 (each), Lot Numbers: 24BMF235 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0124-2025%22
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