FDA-Device2026-05-20Class IPROCESSING DEFECT
Medline cardiac catheterization kits recalled for particulate contamination in fluid path
What this means
Medline has identified particles inside the fluid pathways of Namic Manifolds used in cardiac catheterization kits. These kits are used during heart procedures. The contamination could potentially affect the performance of the devices during medical procedures.
- Check your facility's inventory against the affected lot numbers and kit SKUs listed in the recall notice.
- Do not use affected kits. Contact Medline with your kit lot number or SKU for instructions on return or replacement.
- Notify your medical team and patients if any of these kits were used in recent procedures.
The agency's original wording
Hazard
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Intended for
Adults
Illnesses reported
None reported
Sold states
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Affected count
21119 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075; 3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N; 4. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250G; 5. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333D; 6. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333F; 7. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779G; 8. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779I; 9. CLOT RETRIEVAL PACK, Medline Kit Number/SKU DYNJ56140C; 10. TAVR PACK NO SYR, Medline Kit Number/SKU DYNJ62310C; 11. TAVR PACK, Medline Kit Number/SKU DYNJ62310D; 12. TAVR PACK, Medline Kit Number/SKU DYNJ62310F; 13. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911; 14. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911A; 15. CATH PACK, Medline Kit Number/SKU DYNJT6544; 16. LHK, Medline Kit Number/SKU NAM0015; 17. SLU LHK, Medline Kit Number/SKU SAMPC0706.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2147-2026Also reported as
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