FDA DevicesClass I
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardio...
Published: May 20, 2026Recall ID: Z-2140-2026Category: devicesCountry: US
Reason for Recall / Hazard
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Product Description & Identification
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98735 |
| Address 1 | 3 Lakes Dr |
| Code info | UDI/DI each 10193489059182, UDI/DI case 30193489059186, Lot Numbers: 92261, 152082, 163966, 163256. |
| Postal code | 60093-2753 |
| Report date | 20260520 |
| Product type | Devices |
| Product quantity | 1975 units |
| 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.