Medline Industries, LP: Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 2. DBD-MTS,LEFT HEART,KIT, Medline Kit N

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: 21119 kits Lot/code info: Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23KBN009; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23LBI829; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24ABH036; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24BBG055; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24EBO156; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24GBS605; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24IBK765; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25ABR102; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25CBK686; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25DBR341; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25EBB568; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25FBB624; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25GBC747; Medline Kit Number/SKU 60010508: UDI/DI each 101934890403

UPC codes

10193489040340, 40193489040341, 10193489048872, 40193489048873, 10198459580918, 40198459580919, 10198459416590, 40198459416591, 10198459032981, 40198459032982, 10198459258633, 40198459258634, 10195327686499, 40195327686490, 10198459423758, 40198459423759, 10198459477218, 40198459477219, 10198459104299, 40198459104290, 10198459254727, 40198459254728, 10198459393327, 40198459393328, 10195327158699, 40195327158690, 10198459005640, 40198459005641, 10198459558689, 40198459558680, 10195327374198, 40195327374199, 10195327586157, 40195327586158

Source

Official record: FDA (Device enforcement) ↗

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