Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Recall Summary Medline is recalling certain Namic Angiographic Manifolds and cardiopulmonary bypass adaptors, stopcocks, manifolds, and fittings because particles have been found inside the fluid pathway of these devices. The recall affects products distributed across the United States and several international locations including Canada, Australia, and Japan.
- Product
- Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
- Reason
- Medline has identified the presence of particulate within the fluid path of the Manifolds.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-24
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/b8573810-9f6c-4167-be9a-7930214689a9