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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88991

8 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 21, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Boston Scientific Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

8 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 8

HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890

Z-0320-2022
Recall number
Z-0320-2022
Initiated
October 21, 2021
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

Code information

GTIN: 08714729283805 Lot Numbers: 25612668, 25649812, 25704208, 25771760, 25878552, 26000695, 26010387, 26058284, 26087172, 26087173, 26123181, 26324742, 26366746, 26406513, 26429808, 26499853, 26527374, 26573853, 26638827, 26651718, 26665448, 26893604, 27026984, 27074109, 27145234, 27162321, 27255235, 27306699. Exp. 05/19/2022 to 05/13/2023

Distribution pattern

US Nationwide distribution.

device · product 2 of 8

HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545900

Z-0321-2022
Recall number
Z-0321-2022
Initiated
October 21, 2021
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

Code information

GTIN: 08714729283812 Lot Numbers: 25576719, 25576720, 25576721, 25576769, 25611564, 25612669, 25612670, 25612671, 25612673, 25612674, 25623377, 25623378, 25623379, 25623380, 25623381, 25623382, 25623383, 25623384, 25640115, 25649813, 25649816, 25678821, 25678826, 25678831, 25678836, 25680096, 25704209, 25704210, 25704211, 25704212, 25704213, 25704214, 25704215, 25704216, 25739146, 25739147, 25739149, 25739150, 25771761, 25771762, 25771763, 25771764, 25771765, 25771766, 25771767, 25771768, 25771769, 25771770, 25771771, 25836081, 25836082, 25878553, 25878554, 25878555, 25894783, 25916270, 25916271, 25916445, 25916446, 25940122, 25940123, 25947675, 25947677, 25947678, 25947900, 25947902, 25947904, 25947905, 25975766, 25975767, 25975768, 25975769, 25975770, 25975771, 25975772, 25975773, 26000472, 26000473, 26000474, 26000475, 26000696, 26000697, 26000698, 26000699, 26010388, 26010389, 26010390, 26010391, 26058285, 26058286, 26087174, 26087175, 26087176, 26087177, 26087178, 26087179, 26087720, 26087721, 26087722, 26087723, 26087724, 26087725, 26087726, 26087727, 26087728, 26087729, 26087730, 26087731, 26087732, 26123182, 26123183, 26123184, 26123185, 26123244, 26123245, 26123246, 26175465, 26175466, 26175467, 26175468, 26207974, 26207975, 26207976, 26207977, 26207978, 26207979, 26207980, 26207981, 26207982, 26238131, 26240367, 26247246, 26247247, 26283625, 26283626, 26283627, 26283628, 26283629, 26283630, 26283631, 26324745, 26324747, 26344528, 26344529, 26348351, 26356445, 26366747, 26366748, 26366749, 26366750, 26366751, 26366752, 26406514, 26406515, 26406516, 26406517, 26406518, 26406519, 26406520, 26429809, 26435534, 26435535, 26435536, 26444430, 26447362, 26447363, 26449367, 26456914, 26456915, 26473765, 26473766, 26473767, 26473768, 26495948, 26499146, 26501878, 26511846, 26512444, 26512445, 26512446, 26512447, 26512448, 26512449, 26512450, 26512451, 26540309, 26556786, 26556787, 26559139, 26559540, 26559541, 26559546, 26559547, 26581401, 26581402, 26581403, 26581404, 26581405, 26582100, 26582101, 26582102, 26588068, 26588069, 26588070, 26588071, 26628440, 26628441, 26628442, 26638828, 26638829, 26651717, 26660956, 26665449, 26665450, 26665458, 26665560, 26677021, 26685872, 26685873, 26685874, 26699186, 26699187, 26699188, 26699189, 26699190, 26699191, 26728358, 26728359, 26728780, 26728781, 26769421, 26778891, 26778892, 26778893, 26792383, 26792384, 26792386, 26793780, 26793781, 26808194, 26808195, 26808196, 26818638, 26818639, 26818880, 26818881, 26848716, 26848717, 26848718, 26848719, 26872354, 26872355, 26872356, 26872357, 26872358, 26906626, 26906627, 26906628, 26906629, 26906630, 26906631, 26919043, 26919044, 26919045, 26919046, 26919047, 26940194, 26956470, 26956471, 26956472, 26956473, 26956474, 26956475, 26956476, 26956477, 26956478, 26956479, 27008818, 27008819, 27025671, 27027293, 27027294, 27027295, 27027296, 27027297, 27027298, 27027299, 27065828, 27065829, 27074111, 27074112, 27100015, 27100016, 27110095, 27121580, 27121581, 27121622, 27121623, 27121624, 27162322, 27162323, 27162324, 27162325, 27182893, 27182894, 27182895, 27183306, 27183307, 27183308, 27203712, 27203713, 27203714, 27203715, 27203716, 27203717, 27203718, 27203719, 27203760, 27203761, 27203762, 27203763, 27203764, 27203765, 27203766, 27203767, 27255211, 27255212, 27255213, 27255214, 27265231, 27269950, 27269951, 27269953, 27269954, 27269955, 27308420, 27308421, 27335099, 27335460, 27340626, 27340636, 27340637, 27347590, 27347591, 27384704, 27393782, 27408924 Exp. 05/10/2022 to 05/31/2023

Distribution pattern

US Nationwide distribution.

device · product 3 of 8

HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910

Z-0322-2022
Recall number
Z-0322-2022
Initiated
October 21, 2021
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

Code information

GTIN: 8714729283829 Batches: 25623385, 25678822, 25739151, 25771772, 25975774, 26010392, 26051928, 26087733, 26123186, 26175469, 26406521, 26429810, 26456904, 26579839, 26581406, 26601326, 26660957, 26793786, 26896864, 27026985, 27096335, 27226570, 27255234, 27400203. Exp. 05/23/2022 to 05/28/2023

Distribution pattern

US Nationwide distribution.

device · product 4 of 8

HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545920

Z-0323-2022
Recall number
Z-0323-2022
Initiated
October 21, 2021
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

Code information

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. 05/10/2022 to 05/26/2023

Distribution pattern

US Nationwide distribution.

device · product 5 of 8

HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545930

Z-0324-2022
Recall number
Z-0324-2022
Initiated
October 21, 2021
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

Code information

Batches: 25644951, 25649190, 25650286, 25651334, 25654287, 25947916, 25947918, 26010397, 26058298, 26406532, 26435581, 26449368, 26533973, 26555544, 26868194, 27074110, 27269956, 27384708. GTIN: 08714729283843 Exp. 05/27/2022 to 05/26/2023

Distribution pattern

US Nationwide distribution.

device · product 6 of 8

HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940

Z-0325-2022
Recall number
Z-0325-2022
Initiated
October 21, 2021
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

Code information

Batches: 25608760, 25612672, 25649815, 25649818, 25649822, 25649823, 25649827, 25649828, 25649832, 25649833, 25678824, 25678828, 25678829, 25678833, 25678834, 25678838, 25680098, 25680099, 25704224, 25704225, 25704226, 25704227, 25704228, 25704229, 25739159, 25739160, 25739161, 25739162, 25739163, 25739164, 25739165, 25739166, 25739167, 25739168, 25788242, 25789369, 25789801, 25836093, 25836094, 25836095, 25836096, 25836097, 25836098, 25836099, 25836140, 25836141, 25836142, 25836143, 25836144, 25836145, 25878556, 25894780, 25894781, 25894782, 25916457, 25939485, 25939684, 25940126, 25940127, 25940131, 25947920, 25947921, 25975779, 25975780, 25975781, 25975782, 25975783, 25975784, 25975785, 25975786, 25975787, 26000581, 26000582, 26000583, 26000584, 26051925, 26051926, 26051927, 26058299, 26058420, 26058421, 26058422, 26058425, 26096221, 26096222, 26096223, 26099224, 26123192, 26123193, 26123194, 26123195, 26123196, 26123250, 26123251, 26175474, 26175475, 26175476, 26175477, 26175478, 26175479, 26175500, 26207992, 26207993, 26207994, 26207995, 26207996, 26207997, 26207998, 26238135, 26240374, 26240376, 26240377, 26240378, 26247258, 26247259, 26247280, 26247281, 26247282, 26247283, 26247284, 26247285, 26284144, 26284145, 26284146, 26284147, 26284148, 26284149, 26284150, 26284151, 26324756, 26324758, 26324760, 26324762, 26324764, 26324765, 26324767, 26350408, 26351999, 26356443, 26366758, 26366759, 26366760, 26366761, 26366762, 26366763, 26366764, 26366765, 26366766, 26395974, 26406533, 26406534, 26406535, 26406536, 26406537, 226435588, 26456918, 26456919, 26473775, 26473776, 26473777, 26473778, 26491312, 26491313, 26491314, 26491319, 26491480, 26512487, 26512488, 26512490, 26527375, 26527376, 26527377, 26527378, 26551465, 26551466, 26551467, 26551468, 26551470, 26577498, 26613121, 26614494, 26614495, 26614496, 26614497, 26614498, 26614800, 26614801, 26628445, 26628446, 26628447, 26651711, 26651712, 26665036, 26665037, 26665038, 26665039, 26665360, 26665361, 26696684, 26696685, 26696686, 26696687, 26706788, 26706789, 26706790, 26706791, 26706792, 26706793, 26706794, 26760454, 26760456, 26760458, 26760459, 26760520, 26760521, 26760522, 26760523, 26760524, 26760525, 26779085, 26799125, 26799126, 26799127, 26799128, 26799129, 26818882, 26818883, 26818884, 26818885, 26818886, 26818887, 26818888, 26818889, 26818890, 26818891, 26818892, 26848726, 26848727, 26848728, 26848729, 26848730, 26848731, 26888163, 26888164, 26888165, 26888166, 26888167, 26888168, 26910996, 26919048, 26919049, 26919050, 26919051, 26919341, 26990595, 26990596, 26990598, 26990599, 26990980, 26990981, 26990982, 27008813, 27008814, 27008815, 27008816, 27008817, 27009671, 27027284, 27027285, 27027286, 27027287, 27027288, 27055010, 27055018, 27062058, 27065836, 27065837, 27065838, 27065839, 27074113, 27074114, 27100243, 27100244, 27110098, 27110099, 27110720, 27121586, 27121587, 27121588, 27121589, 27148635, 27162330, 27162331, 27162332, 27183300, 27183301, 27183302, 27203774, 27203775, 27203776, 27203777, 27203778, 27203779, 27255225, 27255226, 27255227, 27255228, 27255229, 27255230, 27255231, 27255232, 27255233, 27265232, 27269957, 27269958, 27269959, 27308426, 27308427, 27335095, 27335096, 27335097, 27347594, 27347595, 27347596, 27384709, 27393786, 27407169, 27408779, 27408920, 274089216406538, 26426920, 26435582, 26435583, 26435585, 26435586, 26435587, 26435588, 26456918, 26456919, 26473775, 26473776, 26473777, 26473778, 26491312, 26491313, 26491314, 26491319, 26491480, 26512487, 26512488, 26512490, 26527375, 26527376, 26527377, 26527378, 26551465, 26551466, 26551467, 26551468, 26551470, 26577498, 26613121, 26614494, 26614495, 26614496, 26614497, 26614498, 26614800, 26614801, 26628445, 26628446, 26628447, 26651711, 26651712, 26665036, 26665037, 26665038, 26665039, 26665360, 26665361, 26696684, 26696685, 26696686, 26696687, 26706788, 26706789, 26706790, 26706791, 26706792, 26706793, 26706794, 26760454, 26760456, 26760458, 26760459, 26760520, 26760521, 26760522, 26760523, 26760524, 26760525, 26779085, 26799125, 26799126, 26799127, 26799128, 26799129, 26818882, 26818883, 26818884, 26818885, 26818886, 26818887, 26818888, 26818889, 26818890, 26818891, 26818892, 26848726, 26848727, 26848728, 26848729, 26848730, 26848731, 26888163, 26888164, 26888165, 26888166, 26888167, 26888168, 26910996, 26919048, 26919049, 26919050, 26919051, 26919341, 26990595, 26990596, 26990598, 26990599, 26990980, 26990981, 26990982, 27008813, 27008814, 27008815, 27008816, 27008817, 27009671, 27027284, 27027285, 27027286, 27027287, 27027288, 27055010, 27055018, 27062058, 27065836, 27065837, 27065838, 27065839, 27074113, 27074114, 27100243, 27100244, 27110098, 27110099, 27110720, 27121586, 27121587, 27121588, 27121589, 27148635, 27162330, 27162331, 27162332, 27183300, 27183301, 27183302, 27203774, 27203775, 27203776, 27203777, 27203778, 27203779, 27255225, 27255226, 27255227, 27255228, 27255229, 27255230, 27255231, 27255232, 27255233, 27265232, 27269957, 27269958, 27269959, 27308426, 27308427, 27335095, 27335096, 27335097, 27347594, 27347595, 27347596, 27384709, 27393786, 27407169, 27408779, 27408920, 27408921. GTIN: 08714729283850 Exp. 05/18/2022 to 05/31/2023

Distribution pattern

US Nationwide distribution.

device · product 7 of 8

HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950

Z-0326-2022
Recall number
Z-0326-2022
Initiated
October 21, 2021
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

Code information

Batches: 25571372, 25673064, 25836146, 26010398, 26058426, 26123197, 26175501, 26216321, 26473779, 26759413, 26784680, 26848732, 26946145, 27121592, 27340635, 27393787 GTIN: 08714729283867 Exp. 05/09/2022 to 05/27/2023

Distribution pattern

US Nationwide distribution.

device · product 8 of 8

HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960

Z-0327-2022
Recall number
Z-0327-2022
Initiated
October 21, 2021
Classification
Class II
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Reason for recall

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

Code information

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Distribution pattern

US Nationwide distribution.