Z-2146-2026 Class I Ongoing
FDA device recall Z-2146-2026 was initiated by Medline Industries, LP on March 24, 2026 and is designated Class I. Reason for recall: Medline has identified the presence of particulate within the fluid path of the Manifolds. The recall status is ongoing. Affected quantity: 0 kits.
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2026
- Initiation Date
- March 24, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 0 kits
Product Description
Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B
Reason for Recall
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Distribution Pattern
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Code Information
UDI/DI each 10889942814619, UDI/DI case 40889942814610, Lot Number: 26CMC977