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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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