Recall Z-1806-2024— MEDLINE INDUSTRIES, LP - Northfield

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-03-12. FDA's recall record names no specific 510(k) clearance for this event. Product: namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; c) LEFT HEART KIT, REF 60071822; d) LEFT HEART KIT, REF 60080085; e) CONVENIENCE KIT, REF 60100055; f) CONVENIENCE KIT, REF 60101041; g) CONVENIENCE KIT, REF 60120336; h) LEFT HEART KIT, REF 60131446; i) 3 VALVE MANIFOLD OFF KIT WITH SQUEEZE CONTRAST CONTROLLER AND PROTECTION STATION, REF 60140798; j) CONVENIENCE KIT, REF 60142592; k) LEFT HEART KIT, REF 60183972; l) FOUR VALVE MANIFOLD KIT, REF 60210209; m) RIGHT HEART KIT, REF 60210862; n) LEFT HEART KIT, REF 600705710; o) CONVENIENCE KIT, REF 600803410; p) TUBING KIT; REF 601322913; q) LEFT HEART KIT, REF 60032582A. Reason: Products have a lack of sterility assurance..

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Classification

Class II

Status

Ongoing

Initiated

2024-03-12

Firm location

Northfield, IL, United States

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