Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Reason for recall: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. Distribution: Worldwide distribution: US (nationwide) including Puerto Rico (PR) and OUS (foreign) to countries of: Canada (CA), Netherlands (NL), Australia (AU), Korea, Republic of (KR), Sri Lanka (LK), Pakistan (PK), Japan (JP), United Arab Emirates (AE), Singapore (SG) and Slovakia (SK). Quantity: 2630369 units Lot/code info: 1. Medline SKU 70075027, UDI/DI each 10193489065831, UDI/DI case 30193489065835, Lot Numbers: 0000077215, 0000079109, 0000082289, 0000084363, 0000090369, 0000107045, 0000114900, 0000120770, 0000122275, 0000125531, 0000125834, 0000132127, 0000132132, 0000135020, 0000135023, 0000137279, 0000141698, 0000141699, 0000144189, 0000147731, 0000149644, 0000151436; 2. Medline SKU 70085007, UDI/DI each 10193489065954, UDI/DI case 30193489065958, Lot Numbers: 0000074193, 0000077204, 0000077974, 0000079512, 0000083156, 0000085956, 0000086070, 0000086483, 0000090174, 0000090816, 0000090917, 0000092492, 0000094095, 0000096914, 0000098330, 0000099425, 0000100711, 0000100826, 0000101994, 0000113588, 0000116407, 0000116708, 0000117321, 0000119569, 0000120349, 0000121439, 0000121700, 0000123467, 0000124590, 0000126063, 0000127845, 0000132989, 0000134342, 0000134345, 0000134741, 0000136418, 0000138294, 0000141336, 0000147492, 0000149666, 0000150547, 0000152486, 0000152797, 0000155541, 0000156129, 0000156574, 0000158566, 0000164128, 0000166270, 0000167879, 0000167880, 0000168660, 0000170215, 0000170237, 0000171147, 0000172275, 0000173410, 0000187298, 0000187601, 0000187638; 3. Medline SKU 70085107, UDI/DI each 10193489065961, UDI/DI case 20193489065968, Lot Numbers: 0000075384, 0000096807, 0000133033, 0000147541, 0000154518, 0000167033, 0000179525; 4. Medline SKU 70087007, UDI/DI each 0000075190, G4UDI/DI case 10193489065985, Lot Numbers: 0000075190, 0000075227, 0000078287, 0000089093, 0000090805
10193489065831, 30193489065835, 10193489065954, 30193489065958, 10193489065961, 20193489065968, 10193489065985, 10193489065992, 30193489065996, 10193489066012, 30193489066016, 10193489066036, 30193489066030, 10193489066043, 30193489066047, 10193489066067, 30193489066061, 10193489066074, 30193489066078, 10193489066104, 30193489066108, 10193489066739, 30193489066733, 10193489066838, 30193489066832, 10193489066852, 30193489066856, 10193489066876, 20193489066873, 10193489066883, 30193489066887, 10193489066906, 30193489066900
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.