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Medline Industries, LP: Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C

Medical DevicesSource: FDA (device) · Date: 2026-05-20

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medline Industries, LP
Product
Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C
Reason / hazard
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Classification
Class I
Status
Ongoing
Distribution / sold at
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Recall initiated
2026-03-24
Code info
UDI/DI each 10193489475135, UDI/DI case 40193489475136, Lot Numbers: 23GBR742, 23IBC951, 23JBM554, 23LBK506, 24BBO670, 24GBM624.
Product quantity
107 kits
Voluntary mandated
Voluntary: Firm initiated
City
Northfield
State
IL
Country
United States
Event id
98735
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