namic convenience kits labeled as: PML — Class II medical device recall Z-1428-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-04-02, distributed nationwide. The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near t
| Recall number | Z-1428-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2025-02-12 |
| Classified | 2025-03-21 |
| Reported by FDA | 2025-04-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | NL, NZ, SK |
| Quantity | 4,400 units |
| UPC / GTIN / UDI-DI | 10193489067507, 20193489067504 |
| Lot numbers | 0000140528 |
| Model numbers | 80641722 |
Product
namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit
Reason for recall
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1428-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.