FDAFDA · Alimentos y medicamentos·N.º oficial Z-0323-2022
HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545920
Publicado el 8 de diciembre de 2021 · Inicio del retiro: 21 de octubre de 2021
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
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Qué hacer
Voluntary: Firm initiated
Detalles del retiro
- Fabricante
- Boston Scientific Corporation
- Distribuidor
- US Nationwide distribution.
- Lote
- GTIN: 08714729283836 Batches: 25576770, 25576881, 25576882, 25576883, 25576884, 25576885, 25608762, 25623386, 25623387, 25623388, 25623389, 25623390, 25623391, 25623392, 25623393, 25623394, 25623395, 25623396, 25623397, 25623398, 25649814, 25649817, 25649820, 25649821, 25649825, 25649826, 25649830, 25649831, 25678823, 25678827, 25678832, 25678837, 25680097, 25704217, 25704218, 25704219, 25704220, 25704221, 25704222, 25704223, 25739152, 25739153, 25739154, 25739155, 25739157, 25739158, 25771773, 25771774, 25771775, 25771776, 25771777, 25771778, 25836083, 25836084, 25836085, 25836086, 25836087, 25836088, 25836089, 25836090, 25836091, 25836092, 25878557, 25878558, 25878559, 25878980, 25878981, 25878982, 25878983, 25878984, 25878985, 25940124, 25940125, 25942723, 25947907, 25947909, 25947911, 25947913, 25947915, 25975775, 25975776, 25975777, 25975778, 25995786, 25996198, 26000471, 26000476, 26000477, 26000478, 26000479, 26000580, 26000700, 26010393, 26010394, 26010395, 26010396, 26058288, 26058291, 26058293, 26058294, 26058295, 26058296, 26058297, 26087734, 26087735, 26087736, 26087737, 26087738, 26087739, 26087740, 26087741, 26123187, 26123188, 26123189, 26123190, 26123191, 26123247, 26123248, 26123249, 26175470, 26175471, 26175472, 26175473, 26207983, 26207984, 26207985, 26207986, 26207987, 26207988, 26207989, 26207990, 26207991, 26238132, 26238133, 26238134, 26240368, 26240370, 26240371, 26240373, 26247248, 26247249, 26247250, 26247251, 26247252, 26247253, 26247254, 26247255, 26247256, 26247257, 26283632, 26283633, 26283634, 26283635, 26283636, 26283637, 26283638, 26283639, 26284140, 26284141, 26284142, 26284143, 26324749, 26324751, 26324752, 26324754, 26350404, 26350405, 26350406, 26350407, 26356444, 26366753, 26366754, 26366755, 26366756, 26366757, 26406522, 26406523, 26406524, 26406525, 26406526, 26406527, 26406528, 26406529, 26406530, 26406531, 26426921, 26426922, 26426923, 26428970, 26429811, 26429812, 26435537, 26435538, 26435539, 26435580, 26452047, 26456916, 26456917, 26462399, 26473523, 26473769, 26473770, 26473771, 26473772, 26473773, 26473774, 26495372, 26495950, 26500637, 26500638, 26512452, 26512453, 26512454, 26512455, 26512456, 26512457, 26512458, 26512459, 26512480, 26512481, 26512483, 26512485, 26549972, 26552065, 26556788, 26556789, 26559542, 26559543, 26559544, 26559548, 26581407, 26581408, 26582103, 26582104, 26582105, 26582106, 26582107, 26588072, 26588073, 26588074, 26588075, 26588076, 26628443, 26628444, 26638830, 26638831, 26651713, 26651714, 26651715, 26651716, 26665561, 26665567, 26665571, 26665572, 26665573, 26685875, 26685876, 26685877, 26685878, 26685879, 26699192, 26699193, 26699194, 26699195, 26699196, 26699197, 26728782, 26728784, 26728785, 26759345, 26760530, 26778894, 26778895, 26778896, 26778897, 26778898, 26779080, 26779081, 26779082, 26779083, 26793782, 26793783, 26793784, 26808197, 26808198, 26808199, 26808300, 26808301, 26808302, 26808303, 26848720, 26848721, 26848722, 26848723, 26848724, 26848725, 26871168, 26871169, 26871170, 26871171, 26871172, 26871173, 26871174, 26910997, 26910998, 26910999, 26911840, 26911841, 26911842, 26911845, 26919040, 26919041, 26919042, 26960166, 26960167, 26960168, 26960169, 26960170, 26960171, 26960172, 26960173, 26960174, 26960175, 27009668, 27027289, 27027290, 27027291, 27027292, 27062054, 27062055, 27062056, 27062057, 27065830, 27065831, 27065832, 27065833, 27065834, 27065835, 27100017, 27100018, 27100019, 27100240, 27100241, 27100242, 27110096, 27110097, 27121582, 27121583, 27121584, 27121585, 27121620, 27121621, 27121625, 27148636, 27148637, 27148638, 27162326, 27162327, 27162328, 27162329, 27182896, 27182897, 27182898, 27182899, 27203768, 27203769, 27203770, 27203771, 27203772, 27203773, 27255217, 27255219, 27255220, 27255221, 27255222, 27255223, 27308422, 27308423, 27308424, 27308425, 27335091, 27335092, 27335093, 27335094, 27340629, 27340630, 27340632, 27340633, 27340634, 27340638, 27347592, 27347593, 27384705, 27384706, 27384713, 27384715. Exp.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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