Medline Industries, LP: 1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Number: 65110351; 3. HEART CATH PACK-LF, Medline Kit SKU Number: DYNJ0373285M; 4. ANGI

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: 567675 kits Lot/code info: Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 91637; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 91667; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 92995; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 95615; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 97091; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 102177; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 104282; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 108922; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 110250; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 89290; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 91926; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 98742; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 100867; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lo

UPC codes

10193489040234, 30193489040238, 10193489040319, 30193489040313, 10193489040326, 30193489040320, 10193489040340, 30193489040344, 10193489040685, 30193489040689, 10193489040692, 30193489040696, 10193489040715, 30193489040719, 10193489040746, 30193489040740, 10193489040753, 30193489040757, 10193489091236, 30193489091230, 10193489042351, 30193489042355, 10193489042436, 30193489042430, 10193489042443, 30193489042447, 10193489042580, 30193489042584, 10193489042832, 30193489042836, 10193489042900, 20193489042907, 10193489043006, 30193489043000, 10193489043150, 30193489043154, 10193489043167, 20193489043164, 10193489043174, 30193489043178

Source

Official record: FDA (Device enforcement) ↗

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