FDA recall Z-1429-2025

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160

Reason for recall

The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

Distribution

Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia

Key facts

Status
Ongoing
Initiation date
2025-02-12
Report date
2025-04-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1429-2025