FDAHealthMarch 24, 2026
Medline Industries, LP — Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C
⚠️ Medline has identified the presence of particulate within the fluid path of the Manifolds.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 24, 2026
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
What's affected?
- Product
- Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C
- Lot code
- 23GBR742
Additional details
UDI/DI each 10193489475135, UDI/DI case 40193489475136, Lot Numbers: 23GBR742, 23IBC951, 23JBM554, 23LBK506, 24BBO670, 24GBM624.
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 107 kits.
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