FDAFDA · Alimentos y medicamentos·N.º oficial Z-1824-2024
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
Publicado el 22 de mayo de 2024 · Inicio del retiro: 17 de abril 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
The guide tip can become damaged and result in the tip detaching.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- LeMaitre Vascular, Inc.
- Distribuidor
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Spain.
- Lote
- Item No. A4545, A4548, A4554, A4558, A4568; GTIN: 840663109807, 840663109838, 840663109814, 840663109821, 840663109845; Lot No: SST1004, SST1005, SST1006, SST1007, SST1009, SST1010, SST1013, SST1018, SST1019, SST1020, SST1021, SST1022, SST1023, SST1024, SST1025, SST1026, SST1027, SST1028, SST1029, SST1030, SST1031, SST1032, SST1033, SST1034, SST1035, SST1036, SST1037, SST1038, SST1041, SST1042, SST1043, SST1044, SST1045, SST1046, SST1047, SST1048, SST1049, SST1050, SST1051, SST1054, SST1055, SST1056, SST1057, SST1058, SST1059, SST1060, SST1061, SST1062, SST1063, SST1064, SST1065, SST1066, SST1067, SST1068, SST1071.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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