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.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2143-2026