RecallRadar

FDA Device recall Z-1428-2025

namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722

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

AgencyFDA Device
Recall numberZ-1428-2025
ClassificationClass II
Statusongoing
Initiated2025-02-12
Published2025-04-02
Last updated2026-09-13 11:57 UTC
CompanyMedline Industries Northfield
DistributionUS

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_infoUDI/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

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.