FDAFDA · Alimentos y medicamentos·N.º oficial Z-2451-2024
Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent placement of sutures during open surgical procedures.
Publicado el 7 de agosto de 2024 · Inicio del retiro: 27 de junio de 2024
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
Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Boston Scientific Corporation
- Distribuidor
- Domestic: Nationwide Distribution. International: Pending
- Lote
- UPN: M0068318261 (Pack of 5), M0068318260 (Individual Pack); UDI/DI: 08714729842224 (Pack of 5), 08714729842804 (Individual Pack); Lot Numbers: 30110296, 30110298, 30254839, 30269668, 30277679, 30340398, 30348745, 30361515, 30369786, 30477997, 30485719, 30502470, 30509859, 30566414, 30571306, 30579075, 30594738, 30597768, 30601523, 30601525, 30608273, 30621482, 30622202, 30628533, 30642670, 30671135, 30825890, 30834186, 30849605, 30853891, 30862718, 30870581, 30877151, 30880729, 31248068, 31305827, 31316815, 31324676, 31400076, 31442842, 31459986, 31475463, 31479225, 31488049, 31494812, 31502318, 31509747, 31514250, 31583783, 31592632, 31600746, 31609045, 31621292, 31764817, 31779852, 31791062, 31809880, 31821132, 31866608, 31876830, 31876835, 31876837, 32040502, 32057254, 32146583, 32163271, 32230325, 32238124, 32351364, 32361264, 32370219, 32385442, 32400087, 32409539, 32418519, 32420869, 32447685, 32456405, 32465857, 32478780, 32499939, 32515625, 32518619, 32526697, 32829992, 32915635, 32979863, 32998255, 33008248, 33017302, 33065907, 33069479, 33216295, 33236632, 33259078, 33283648, 33311001, 33319579, 33375040, 33383769, 33394221, 33404930, 33422407, 33424886, 33454127, 33479450, 33530347, 33556283, 33564420, 33618759, 33670919, 33676308, 33815834
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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