Recall Z-2146-2026— Medline Industries, LP

Class I · Ongoing

Class I FDA medical device recall by Medline Industries, LP, initiated 2026-03-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B. Reason: Medline has identified the presence of particulate within the fluid path of the Manifolds..

Recalling firm
Medline Industries, LP
Classification
Class I
Status
Ongoing
Initiated
2026-03-24
Firm location
Northfield, IL, United States

Product description

Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B

Reason for recall

Medline has identified the presence of particulate within the fluid path of the Manifolds.

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