FDA Device recall Z-1428-2025
namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722
- FDA Device
- Class II
- ongoing
- Published 2025-04-02
On 2025-04-02 the FDA classified a Class II recall of namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722 by Medline Industries Northfield, citing the female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1428-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-12 |
| Published | 2025-04-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit
Reason
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
Identifiers
| code_info | UDI/DI 10193489067507 (each), 20193489067504 (case), Lot number 0000140528 |
|---|
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-1428-2025%22
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