This is part of a larger recall. The most authoritative record is FDA-Device / Z-2144-2026.
FDA-Device2026-05-20Class IPROCESSING DEFECT
Medline HEART CATH PACK-LF medical kits recalled for particulate contamination in fluid path
What this means
Medline identified particles inside the fluid pathway of Namic Manifolds used in HEART CATH PACK-LF medical convenience kits. These particles could potentially interfere with the safe operation of the device during cardiac catheterization procedures.
- If you have a HEART CATH PACK-LF kit with Lot Number 26CMC977, stop using it immediately
- Contact Medline or your healthcare facility for instructions on returning or replacing affected kits
- Check your facility's inventory using the UDI/DI numbers 10889942814619 (individual) or 40889942814610 (case)
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
0 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2146-2026More Medline recalls
- FDA-Device2026-09-30Medline neurological surgical kits recalled for elevated endotoxin levels in sponges
- FDA-Device2026-09-30Medline Convenience Kits Major Pack recalled for elevated endotoxin levels in neurological sponges
- FDA-Device2026-09-30Medline Convenience Kits recalled for elevated endotoxin levels in sponges
- FDA-Device2026-09-30Medline sinus convenience kits recalled for sharp brush edges risking cut injury
- FDA-Device2026-09-30Medline surgical convenience kits recalled for elevated endotoxin levels in neurological sponges
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