Medline Industries, LP
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
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,
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →