Medline Industries, LP: Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; 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: 7075 units Lot/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.

UPC codes

10193489059144, 30193489059148

Source

Official record: FDA (Device enforcement) ↗

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