Recall Z-2143-2026— 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: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/SKUDYNJ23532C; 2. CATH LAB PACK, Medline Kit Number/SKUDYNJ65185; 3. ANGIO KIT, Medline Kit Number/SKUVASC1057.. 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: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/SKUDYNJ23532C; 2. CATH LAB PACK, Medline Kit Number/SKUDYNJ65185; 3. ANGIO KIT, Medline Kit Number/SKUVASC1057.
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.