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
Medline HEART CATH PACK-LF kits recalled for particulate contamination
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)
Hazard
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Who it affects
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-PR2026-08-05Medline Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits recalled for connector overheating risk
- FDA-Device2026-07-29Medline surgical convenience kits recalled for quality issues in anesthetic component
- FDA-Device2026-07-29Medline NEURO PACK medical kits recalled for Bacillus contamination
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
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