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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1713-2026

NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007; 2. SYRINGE,8ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70084007; 3. MTS,SYRINGE,8ML,TR/FR,RA,NO,RES,-,P/G, Medline SKU 70084017; 4. SYRINGE,7,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80083007; 5. SYRINGE,8,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80084007; 6. MTO,SYRINGE,8,ML,TR/FR,RA,NO,RES,OEM,PG, Medline SKU 80084017.

Publicado el 15 de abril de 2026 · Inicio del retiro: 27 de febrero de 2026

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Detalles del retiro

Fabricante
Medline Industries, LP
Distribuidor
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).
Lote
1. Medline SKU 70083007, UDI/DI each 10193489065855, UDI/DI case 30193489065859, Lot Numbers: 0000077029, 0000081537, 0000084335, 0000087347, 0000089563, 0000113792, 0000115753, 0000122956, 0000127785, 0000131986, 0000158748, 0000175535, 0000187926; 2. Medline SKU 70084007, UDI/DI each 10193489065893, UDI/DI case 30193489065897, Lot numbers: 0000078186, 0000081539, 0000084274, 0000086756, 0000089554, 0000094842, 0000096918, 0000105613, 0000109479, 0000111244, 0000114562, 0000115421, 0000117317, 0000118251, 0000120265, 0000120769, 0000121714, 0000123466, 0000124589, 0000131984, 0000131989, 0000138071, 0000140322, 0000142850, 0000147002, 0000152069, 0000162694, 0000173507, 0000174662, 0000174773, 0000176555, 0000178806, 0000189895; 3. Medline SKU 70084017, UDI/DI each 10193489065916, UDI/DI case 20193489065913, Lot Numbers: 0000084509, 0000086823, 0000095687, 0000165551, 0000165868, 0000166300; 4. Medline SKU 80083007, UDI/DI each 10193489066753, UDI/DI case 30193489066757, Lot Numbers: 0000097388, 0000127072, 0000135012, 0000137004; 5. Medline SKU 80084007, UDI/DI each 10193489066791, UDI/DI case 30193489066795, Lot Numbers: 0000080553, 0000080919, 0000082969, 0000085041, 0000088044, 0000094514, 0000099870, 0000101882, 0000102372, 0000105155, 0000107328, 0000109442, 0000112810, 0000112966, 0000114317, 0000115744, 0000117572, 0000118722, 0000118962, 0000119950, 0000120931, 0000121305, 0000121393, 0000122583, 0000122606, 0000123102, 0000126198, 0000126566, 0000127132, 0000130798, 0000131678, 0000132838, 0000137176, 0000139543, 0000140507, 0000142057, 0000142279, 0000143110, 0000143264, 0000143714, 0000148872, 0000150059, 0000150488, 0000151054, 0000151295, 0000151300, 0000151768, 0000152754, 0000153438, 0000154148, 0000156028, 0000158045, 0000158122, 0000159113, 0000159652, 0000160479, 0000160753, 0000161269, 0000162083, 0000162090, 0000162336, 0000162895, 0000164540, 0000164541, 0000166504, 0000166983, 0000167995, 0000168000, 0000169147, 0000169560, 0000169793, 0000170823, 0000171778, 0000173402, 0000174087, 0000174697, 0000174747, 0000176011, 0000176240, 0000176850, 0000177923, 0000179193, 0000179414, 0000180511, 0000182186, 0000182779, 0000182782, 0000185643, 0000186234, 0000186874, 0000187362, 0000187363, 0000188837, 0000188842, 0000188845; 6. Medline SKU 80084017, UDI/DI each 10193489066814, UDI/DI case 20193489066811, Lot Numbers: 0000101535, 0000103862, 0000105095, 0000106954, 0000108237, 0000122887, 0000126590, 0000127159, 0000128360, 0000128852, 0000132717, 0000134047, 0000135616, 0000140813, 0000144899, 0000148530, 0000149322, 0000152430, 0000161279, 0000164538, 0000169107, 0000173193, 0000173256, 0000182141, 0000183619, 0000187345, 0000188399.
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

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