FDAFDA · Alimentos y medicamentos·N.º oficial Z-0664-2021
IceSphere" 1.5 CX 90¿ Cryoablation Needle
Publicado el 30 de diciembre de 2020 · Inicio del retiro: 18 de noviembre de 2020
Estado reportado al momento de publicación: Completed — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Complaint trend regarding needle shaft gas leaks.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Boston Scientific Corporation
- Distribuidor
- Nationwide
- Lote
- UPN: FPRPR3573 UDIs: 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133 Batch Numbers: U1458, U1457, U1459, U1460, U1461, U1429, U1428, U1426, U1427, U1425, U1430, U1333, U1331, U1232, U1230, U1334, U1332, U1335, U1330, U1229, U1231, U1222, U1221, U1219, U1220, U1184, U1182, U1180, U1179, U1183, U1181, U1162, U1161, U1160, U0982, U0981, U0977, U0980, U0922, U0923, U0920, U0921, U0872, U0870, U0871, U0873, U0519, U0518, U0508, U0303, U0300, U0301, U0302, U0472, U0299, U0298, U0262, U0260, U0259, U0257, U0258, U0261, U0239, U0240, U0219, X0230, U0220, U0207, U0193, U0184, U0168, U0169, U0167, U0125, U0124, U0126, U0127, U0128, U0099, U0098, U0058, U0059, U0057, U0052, U0051, U0018, U0017, T0802, T0828, T0829, T0803, T0820, T0798, T0800, T0799, T0780, T0704, T0694, T0695, T0703, T0682, T0683, T0671, T0670, T0655, T0656, T0658, T0657, T0653, T0654, T0593, T0594, T0583, T0584, T0577, T0578, T0567, T0458, T0455, T0456, T0379, T0378, T0366, T0367, T0350, T0349, T0
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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