Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E
Publicado el 24 de abril de 2024 · Inicio del retiro: 19 de diciembre de 2023
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
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Smiths Medical ASD Inc.
- Distribuidor
- Worldwide distribution.
- Lote
- All serial numbers for pumps manufactured or serviced with these potentially affected Barrel Clamp Guides between Jul-2016 and Apr-2021. a. 3010, UDI/DI none, Serial Numbers: M03315, M03910; b. 3010A, UDI/DI 10610586032097, Serial Numbers: M04601, M05551, M05782, M06829, M07259, M07334, M07339, M07342, M07345, M07371, M08269, M08750, M08815, M10253, M10267, M10871, M10876, M10965, M11872, M11896, M11899, M11901, M11905, M11915; c. 3010E, UDI/DI none, Serial Numbers: M05179
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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