Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
USNamic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Recalling Firm: Medline Industries, LP
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 64038301; 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 10193489059168, UDI/DI case 30193489059162, Lot Numbers: 89631, 92244, 92464, 93148, 94033, 94851, 101093, 101989, 103550, 109976, 112236, 112333, 114288, 115691, 121707, 126993, 137933, 142147, 162786, 191812, |
| Postal code | 60093-2753 |
| Report date | 20260520 |
| Product type | Devices |
| Product quantity | 38175 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 |
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Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass I
- DistributionUS (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
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🚨 SAFETY ALERT: Medline Industries, LP - Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting. Check if your household is affected: https://therecallfile.com/recalls/namic-angiographic-manifold-custom-medline-product-number-sku-64038301/FDA-Z-2139-2026
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