Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Recall Summary Medline is recalling Namic Angiographic Manifolds and certain cardiopulmonary bypass adaptors, stopcocks, manifolds, and fittings because particles have been found in the fluid pathway of these devices. The recall affects products distributed nationwide in the U.S. and in several other countries including Canada, Australia, Japan, and others.
- Product
- Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; 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/d64ef53f-17f0-43f6-ab19-9629e020523f