Recall Z-1429-2025— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-1429-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-12

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2025-02-12. It names one FDA 510(k) clearance: K910764. Product: namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160. Reason: The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2025-02-12
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K910764 — THE PERCEPTOR(TM) STAND ALONE TRANSDUCERNorth American Instrument Corp.·cleared 1991-04-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.