FDA Enforcement
Class I
Ongoing
Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C
Recall: Z-2148-2026
·
Reported May 20, 2026
Enforcement
- Recall Number
- Z-2148-2026
- Event ID
- 98735
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medline Industries, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- May 20, 2026
- Initiation Date
- March 24, 2026
- Classification Date
- May 8, 2026
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753, United States
Description
Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C
Reason
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Code Info
UDI/DI each 10193489475135, UDI/DI case 40193489475136, Lot Numbers: 23GBR742, 23IBC951, 23JBM554, 23LBK506, 24BBO670, 24GBM624.
Distribution
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Quantity
107 kits