FDA DevicesClass I
Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART ...
Published: May 20, 2026Recall ID: Z-2146-2026Category: devicesCountry: US
Reason for Recall / Hazard
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Product Description & Identification
Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B
Affected Products
Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98735 |
| Address 1 | 3 Lakes Dr |
| Code info | UDI/DI each 10889942814619, UDI/DI case 40889942814610, Lot Number: 26CMC977 |
| Postal code | 60093-2753 |
| Report date | 20260520 |
| Product type | Devices |
| Product quantity | 0 kits |
| Reason for recall | Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260324 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260508 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass I
- DistributionUS (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.