FDA-Device2026-05-20Class IPROCESSING DEFECT
Medline medical convenience kits with Namic Manifold recalled for particulate contamination
OTHERNationwide distribution
Medline catheter lab kits recalled for particulate contamination
Medline identified particles inside the fluid pathways of Namic Manifolds used in three medical convenience kits: Angiography Cath Lab, Cath Lab Pack, and Angio Kit. These particles could potentially affect the performance of the manifold during use. Approximately 508 kits have been distributed across the U.S. and several other countries.
- Check if your facility has any of the affected kit numbers: DYNJ23532C, DYNJ65185, or VASC1057.
- Review the lot numbers provided by Medline to identify affected inventory.
- Contact Medline immediately if you have affected kits to discuss appropriate actions.
- Do not use affected kits until you have confirmed they are safe or received replacement instructions from Medline.
Hazard
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Sold states
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Affected count
508 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2143-2026More Medline Industries, LP recalls
- FDA-Device2026-05-20Medline Namic Preceptor blood pressure manifold recalled for particulate contamination
- FDA-Device2026-05-20Medline TAVI medical convenience kits recalled for particulate contamination in fluid path
- FDA-Device2026-05-20Medline cardiac catheterization manifold kits recalled for particulate contamination
- FDA-Device2026-05-20Medline Namic Angiographic Manifold recalled for particulate contamination in fluid path
- FDA-Device2026-05-20Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
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