Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
USNamic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; 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 64038200; 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 10193489059144, UDI/Di case 30193489059148, Lot Numbers: 90184, 94779, 97786, 106351, 108597, 109876, 114056, 114989, 115459, 115931, 116358, 116865, 118245, 122974, 126077, 127795, 129531, 130557, 136114, 150501, 151591, 152772, 154514, 156045, 160318, 163255, 168053. |
| Postal code | 60093-2753 |
| Report date | 20260520 |
| Product type | Devices |
| Product quantity | 7075 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 64038200; 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-64038200/FDA-Z-2138-2026
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