Medline Industries, LP: Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

Hazard

Medline has identified the presence of particulate within the fluid path of the Manifolds.

Details from the source

Reason for recall: Medline has identified the presence of particulate within the fluid path of the Manifolds. Distribution: US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK. Quantity: 38175 units Lot/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,

UPC codes

10193489059168, 30193489059162

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.