FDA-Device2026-05-20Class IPROCESSING DEFECT
Medline TAVI medical convenience kits recalled for particulate contamination in fluid path
What this means
Medline has identified particulate (small particles) in the fluid path of Namic Manifolds within certain TAVI medical convenience kits. The kits were distributed nationwide and internationally. No injuries have been reported.
- Check if you have one of the affected lot numbers: 23GBR742, 23IBC951, 23JBM554, 23LBK506, 24BBO670, or 24GBM624.
- Stop using the kit if you have an affected lot number.
- Contact Medline Industries for instructions on inspection, replacement, or return.
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
107 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2148-2026More Medline recalls
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