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Class 2 Device Recall K113551 Esophageal TTS Stent
K123205 Esophageal TTS Stent
K080782 NitiS Esophageal Stent |
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Date Initiated by Firm |
October 18, 2019 |
Create Date |
February 14, 2020 |
Recall Status1 |
Terminated 3 on October 15, 2021 |
Recall Number |
Z-1229-2020 |
Recall Event ID |
84742 |
510(K)Number |
K123205 K113551 K080782
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Product Classification |
Prosthesis, esophageal - Product Code ESW
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Product |
Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, ES1815B, ES1610F, ES1612F, ES1615F, ES2006F, ES2008F, ES2010F;
Esophageal TTS Stent, REF: EST1806F, EST2012F, EST2012B, EST2015F, EST2008F, EST1808F, EST1814F, EST1810F, EST2010F
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Code Information |
Serial #: 16D5429C9IE565, 16K4777C9IE566, 16K4066C9IE567, 17H3384C9IE568, 16L1711C9IE589, 18K4093C9IE590, 19H4952C9IE515, 19F2183C9IE516, 19H4108C9IE517, 19H2616C9IE518, 19H3454C9IE519, 19F2181C9IE520, 18K1514C9IE521, 19F2182C9IE522, 19H4107C9IE523, 19F0992C9IE524, 18K4123C9IE525, 19E5708C9IE526, 19E5232C9IE527, 19F4232C9IE528, 19H2615C9IE529, 19H3455C9IE530, 19H4897C9IE531, 19B4591C9IE532, 19H3052C9IE533, 19A5788C9IE534, 19C7871C9IE535, 19D7958C9IE536, 19F5937C9IE537, 19G0615C9IE538, 19G1204C9IE539, 19G2208C9IE540, 19G3296C9IE541, 19G3421C9IE542, 19G3422C9IE543, 19G4536C9IE544, 19G4537C9IE545, 19G4558C9IE546, 19G4559C9IE547, 19G4952C9IE548, 19G5440C9IE549, 19G6408C9IE550, 19G7534C9IE551, 19G7535C9IE552, 19H3453C9IE553, 19H4278C9IE554, 19H4279C9IE555, 19H4576C9IE556, 19H4852C9IE557, 19H4979C9IE558, 19H4980C9IE559, 19H1215C9IE560, 19H4088C9IE561, 19H4577C9IE562, 19H4629C9IE563, 19H4851C9IE564, 19D7674C9IE569, 19E0233C9IE570, 19E2071C9IE571, 19E3052C9IE572, 19E3225C9IE573, 19F1089C9IE574, 19F2200C9IE575, 19F2671C9IE576, 19F3104C9IE577, 19F3918C9IE578, 19G1847C9IE579, 19G2531C9IE580, 19G3645C9IE581, 19G4535C9IE582, 19G5986C9IE583, 19G7857C9IE584, 19H4280C9IE585, 19H4977C9IE586, 19H4978C9IE587, 19H5135C9IE588, 16D6106C9IE663, 13F0021C9IE664, 16H4826C9IE665, 16D5894C9IE666, 17H3096C9IE667, 16L1621C9IE669, 16L5518C9IE670, 16D6018C9IE671, 16D5650C9IE672, 16L1991C9IE673, 19B4446C9IE674, 19B4688C9IE675, 19B4986C9IE676, 18K3870C9IE677, 18K3871C9IE678, 18K4092C9IE679, 16D5646C9IE668, 19G4709C9IE614, 19H3229C9IE615, 19F2792C9IE616, 19G5683C9IE617, 19H5127C9IE618, 19H1069C9IE619, 19G7575C9IE620, 19G3288C9IE621, 19G4825C9IE622, 19H5594C9IE623, 19G5931C9IE624, 19H1879C9IE625, 19H3228C9IE626, 19H3411C9IE627, 19G7011C9IE628, 19H5561C9IE629, 19H1821C9IE630, 19H6164C9IE631, 19G7183C9IE632, 19H5126C9IE633, 19G6820C9IE634, 19G7770C9IE635, 19H1313C9IE636, 19G4710C9IE637, 19H3410C9IE638, 19E7223C9IE639, 19E7681C9IE640, 19E7683C9IE641, 19F0124C9IE642, 19F0125C9IE643, 19F1681C9IE644, 19F3419C9IE645, 19F5330C9IE646, 19F6909C9IE647, 19H2571C9IE648, 19H2617C9IE649, 19H2618C9IE650, 19H3133C9IE651, 19H3134C9IE652, 19H3194C9IE653, 19H3195C9IE654, 19H4838C9IE655, 19H4839C9IE656, 19H5434C9IE657, 19H5435C9IE658, 18B1255C9IE659, 18E5617C9IE660, 18F1781C9IE661, 18G3000C9IE662, 19C5822C9IE680, 19F0295C9IE681, 19F1376C9IE682, 19F2066C9IE683, 19F2165C9IE684, 19F2744C9IE685, 19F2993C9IE686, 19F3375C9IE687, 19F3533C9IE688, 19F4913C9IE689, 19F4964C9IE690, 19F5200C9IE691, 19F5203C9IE692, 19G1871C9IE693, 19G3427C9IE694, 16D5343C9IE881, 19F4265C9IE861, 19H1168C9IE862, 19F1979C9IE863, 19F4530C9IE864, 19H1167C9IE865, 19G4646C9IE866, 19G6005C9IE867, 19G2290C9IE868, 19H1330C9IE869, 19G7319C9IE870, 19G5686C9IE871, 19F4442C9IE872, 19H0088C9IE873, 19F3924C9IE874, 19H5212C9IE875, 19G7395C9IE876, 19G7497C9IE877, 19G4517C9IE878, 19F4443C9IE879, 19G3952C9IE880 |
Recalling Firm/ Manufacturer |
Taewoong Medical Co., Ltd. 14 Gojeong-ro, Wolgot-Myeon, Gimpo-Si, Gyeonggi-Do Korea (the Republic of)
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Manufacturer Reason for Recall |
Misprinted IFUs shipped with esophageal stents
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FDA Determined Cause 2 |
Error in labeling |
Action |
On 10/18/19, an Esophageal Stent Device Return notices were emailed to the U.S. distributor who was asked to stop releasing products. The distributor was further asked to do the following for products already distributed: please send customers a notification to stop using the product immediately and to return affected product. Then the distributor was asked to return all affected products in their possession including returned products to the manufacturer. e-mail contact: bclee@stent.net |
Quantity in Commerce |
178 |
Distribution |
U.S.: IN |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = ESW and Original Applicant = TAEWOONG MEDICAL CO., LTD
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