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Medical device recalls reported in 2019

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ReportedRecallClassProductFirm
2019-05-15Z-1308-2019Class IIConMed Anchor Tissue Retrieval SystemConmed Corporation
2019-05-15Z-1309-2019Class IIConMed Anchor Tissue Retrieval System"Conmed Corporation
2019-05-08Z-1223-2019Class IIOMNIPORE Surgical Implant Petite ParanasalMatrix Surgical Holdings, LLC
2019-05-08Z-1224-2019Class IIOMNIPORE Surgical Implant Petite ParanasalMatrix Surgical Holdings, LLC
2019-05-08Z-1225-2019Class IIConcorde LiftDePuy Spine, Inc.
2019-05-08Z-1226-2019Class IIConcorde LiftDePuy Spine, Inc.
2019-05-08Z-1233-2019Class IISiemens ADVIA Centaur aTGSiemens Healthcare Diagnostics, Inc
2019-05-08Z-1234-2019Class IISiemensADVIA Centaur aTGSiemens Healthcare Diagnostics, Inc
2019-05-08Z-1235-2019Class IISiemens Atellica IM aTGSiemens Healthcare Diagnostics, Inc
2019-05-08Z-1236-2019Class IIAtellica IM aTGSiemens Healthcare Diagnostics, Inc
2019-05-08Z-1237-2019Class IIDELFIA¿ hCG KitPerkinElmer Life and Analytical Sciences, Wallac, OY
2019-05-08Z-1238-2019Class IIAutoDELFIA¿ hCG KitPerkinElmer Life and Analytical Sciences, Wallac, OY
2019-05-08Z-1239-2019Class IIAutoDELFIA¿ hCG KitPerkinElmer Life and Analytical Sciences, Wallac, OY
2019-05-08Z-1240-2019Class IIIngenia Ambition SPhilips Medical Systems Nederlands
2019-05-08Z-1241-2019Class IIMedivanceBard Medical Division
2019-05-08Z-1242-2019Class IIFilmArray GastrointestinalBioFire Diagnostics, LLC
2019-05-08Z-1243-2019Class IIEZ Derm Porcine XenograftMolnlycke Health Care, Inc
2019-05-08Z-1244-2019Class IISOMATOM ConfidenceSiemens Medical Solutions USA, Inc
2019-05-08Z-1245-2019Class IISOMATOM Definition EdgeSiemens Medical Solutions USA, Inc
2019-05-08Z-1246-2019Class IISOMATOM Edge PlusSiemens Medical Solutions USA, Inc
2019-05-08Z-1247-2019Class IISOMATOM Definition AS with Option syngo DE Scan for Single SourceSiemens Medical Solutions USA, Inc
2019-05-08Z-1248-2019Class IIBaxter SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation
2019-05-08Z-1249-2019Class IIcobas e 801 immunoassay analyzerRoche Diagnostics Corporation
2019-05-08Z-1250-2019Class IIFetal Spiral ElectrodePhilips North America, LLC
2019-05-08Z-1251-2019Class IIMRIdian Linac Radiation Therapy SystemViewray, Inc.
2019-05-08Z-1252-2019Class IIICAROLINACarolina Liquid Chemistries
2019-05-08Z-1253-2019Class IIICAROLINACarolina Liquid Chemistries
2019-05-08Z-1254-2019Class IIG-6-PDH Deficient ControlRandox Laboratories Ltd.
2019-05-08Z-1255-2019Class IIG-6-PDH Normal ControlRandox Laboratories Ltd.
2019-05-08Z-1256-2019Class IIIEthyl Alcohol Enzymatic AssayLin-Zhi International Inc
2019-05-08Z-1257-2019Class IIDiscovery NM 630 Product Usage: The Discovery NM 630 is an…GE Healthcare, LLC
2019-05-08Z-1258-2019Class IIDiscovery NM/CT 670 CZTGE Healthcare, LLC
2019-05-08Z-1259-2019Class IIDiscovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670…GE Healthcare, LLC
2019-05-08Z-1260-2019Class IIDiscovery NM/CT 670 ES Product Usage: The GE Discovery NM/CT 670…GE Healthcare, LLC
2019-05-08Z-1261-2019Class IINM 830 Product Usage: The Discovery NM 630 is an all-purpose dual…GE Healthcare, LLC
2019-05-08Z-1262-2019Class IINM/CT 850 Product Usage: The GE NM/CT 850 system is intended for…GE Healthcare, LLC
2019-05-08Z-1263-2019Class IINM/CT 860 Product Usage: The GE NM/CT 860 system is intended for…GE Healthcare, LLC
2019-05-08Z-1264-2019Class IINM/CT 870 CZTGE Healthcare, LLC
2019-05-08Z-1265-2019Class IINM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a…GE Healthcare, LLC
2019-05-08Z-1266-2019Class IIOptima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is…GE Healthcare, LLC
2019-05-01Z-1101-2019Class IIcone-beam CT systemKaVo Dental Technologies LLC
2019-05-01Z-1116-2019Class IEdwards LifesciencesEdwards Lifesciences, LLC
2019-05-01Z-1117-2019Class IEdwards LifesciencesEdwards Lifesciences, LLC
2019-05-01Z-1202-2019Class IIIAquarius CSF1R/RPS14Cytocell Ltd.
2019-05-01Z-1203-2019Class IIThoratec HeartMate 3 Coring ToolThoratec Corp.
2019-05-01Z-1204-2019Class IISiemens Digital Linear Accelerators of type: ARTISTE MV System…Siemens Medical Solutions USA, Inc
2019-05-01Z-1205-2019Class IIRT Elements Software revisions of the RT Elements applications have a…Brainlab AG
2019-05-01Z-1206-2019Class IIArthrex BurrArthrex, Inc.
2019-05-01Z-1207-2019Class IIOnSight 3D Extremity System- X-RayCarestream Health, Inc.
2019-05-01Z-1208-2019Class IITruliant Tibial Fit Tray Cemented SZ 3F / 3TExactech, Inc.
2019-05-01Z-1209-2019Class IIFresenius Kabi CATSmart deviceFenwal Inc
2019-05-01Z-1211-2019Class IICovidien Endo Clinch II Auto Suture GrasperCOVIDIEN LLC
2019-05-01Z-1212-2019Class IICovidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien…COVIDIEN LLC
2019-05-01Z-1213-2019Class IIProcedure kits include devices from the affected lots distributed OUS…COVIDIEN LLC
2019-05-01Z-1214-2019Class IITriMed Hex Cortical Screw 4TriMed Inc.
2019-05-01Z-1215-2019Class IIPerformance Series Sagittal BladeStryker Instruments Div. of Stryker Corporation
2019-05-01Z-1217-2019Class IIPrevent G Safety Winged Blood Collection Set GlideGuangzhou Improve Medical Instruments Co., Ltd.
2019-05-01Z-1218-2019Class IIJelcoSmiths Medical ASD Inc.
2019-05-01Z-1219-2019Class IICryoPatch SG Pulmonary Hemi-Artery PatchCryoLife, Inc.
2019-05-01Z-1220-2019Class IIStAbbott
2019-05-01Z-1221-2019Class IIIMaquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm…GETINGE US SALES LLC
2019-05-01Z-1222-2019Class IIVITROS XT 7600 Integrated SystemOrtho-Clinical Diagnostics
2019-04-24Z-1082-2019Class ISpine & Trauma 3D Navigation 1Brainlab AG
2019-04-24Z-1092-2019Class Iicumedical ChemoClave Vented Vial SpikeICU Medical, Inc.
2019-04-24Z-1093-2019Class Iicumedical ChemoClave Vented Vial SpikeICU Medical, Inc.
2019-04-24Z-1094-2019Class Iicumedical Oncology Kit w/12" Ext Set w/Spiros w/Red CapICU Medical, Inc.
2019-04-24Z-1095-2019Class Iicumedical Oncology Kit w/12"ICU Medical, Inc.
2019-04-24Z-1096-2019Class Iicumedical ChemoLockICU Medical, Inc.
2019-04-24Z-1097-2019Class Iicumedical ChemoLock Closed Vial Spike w/SkirtICU Medical, Inc.
2019-04-24Z-1098-2019Class ISetSource ChemoClave Vented Vial SpikeICU Medical, Inc.
2019-04-24Z-1132-2019Class IIAcusnare PolypectomyWilson-Cook Medical Inc.
2019-04-24Z-1133-2019Class IIFilmArray BCID PanelBioFire Diagnostics, LLC
2019-04-24Z-1134-2019Class IIVICRYL Sutures VICRYL SUTURE 18"Ethicon, Inc.
2019-04-24Z-1135-2019Class IIVICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"Ethicon, Inc.
2019-04-24Z-1136-2019Class IIPDS II SUTURE 18"Ethicon, Inc.
2019-04-24Z-1137-2019Class IIBiomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting…bioMerieux, Inc.
2019-04-24Z-1138-2019Class IIIMAGEnet 6 v1Topcon Medical Systems, Inc.
2019-04-24Z-1139-2019Class IIA warming padPintler Medical LLC
2019-04-24Z-1140-2019Class IIFoot Switches used with Philips MultiDiagnost Eleva with Flat DetectorPhilips Medical Systems Nederlands
2019-04-24Z-1141-2019Class IIFoot Switches used with the following systems: 722001 Allura Xper FD…Philips Medical Systems Nederlands
2019-04-24Z-1142-2019Class IIBrilliance 16 AirPhilips Medical Systems (Cleveland) Inc
2019-04-24Z-1143-2019Class IIBrilliance 64Philips Medical Systems (Cleveland) Inc
2019-04-24Z-1144-2019Class IIBrilliance iCTPhilips Medical Systems (Cleveland) Inc
2019-04-24Z-1145-2019Class IIBilirubin Total GenRoche Diagnostics Corporation
2019-04-24Z-1146-2019Class IILactate GenRoche Diagnostics Corporation
2019-04-24Z-1147-2019Class IITina-quant IgM GenRoche Diagnostics Corporation
2019-04-24Z-1148-2019Class IIBIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterileBioventus, LLC
2019-04-24Z-1149-2019Class II14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kitsMedical Components, Inc dba MedComp
2019-04-24Z-1150-2019Class IISalto TalarisIntegra LifeSciences Corp.
2019-04-24Z-1151-2019Class IISalto Talaris Tibial Ankle Prosthesis TrayIntegra LifeSciences Corp.
2019-04-24Z-1152-2019Class IISalto Talaris Tibial Total Ankle Prosthesis TrayIntegra LifeSciences Corp.
2019-04-24Z-1153-2019Class IISalto Talaris Tibial Total Ankle Prosthesis TrayIntegra LifeSciences Corp.
2019-04-24Z-1154-2019Class IISalto Talaris Tibial Total Ankle Prosthesis TrayIntegra LifeSciences Corp.
2019-04-24Z-1155-2019Class IISalto Talaris Tibial Total Ankle Prosthesis TrayIntegra LifeSciences Corp.
2019-04-24Z-1156-2019Class IISalto Talaris Tibial Total Ankle Prosthesis TrayIntegra LifeSciences Corp.
2019-04-24Z-1157-2019Class IISalto Talaris Tibial Total Ankle Prosthesis TrayIntegra LifeSciences Corp.
2019-04-24Z-1158-2019Class IITibial Total Ankle Prosthesis TrayIntegra LifeSciences Corp.
2019-04-24Z-1159-2019Class IITibial Total Ankle Prosthesis TrayIntegra LifeSciences Corp.
2019-04-24Z-1160-2019Class IITibial Total Ankle Prosthesis TrayIntegra LifeSciences Corp.
2019-04-24Z-1161-2019Class IITibial Total Ankle Prosthesis TrayIntegra LifeSciences Corp.
2019-04-24Z-1162-2019Class IITalar Dome Total Ankle ProsthesisIntegra LifeSciences Corp.
2019-04-24Z-1163-2019Class IITalar Dome Total Ankle ProsthesisIntegra LifeSciences Corp.
2019-04-24Z-1164-2019Class IITalar Dome Total Ankle ProsthesisIntegra LifeSciences Corp.
2019-04-24Z-1165-2019Class IITalar Dome Total Ankle ProsthesisIntegra LifeSciences Corp.
2019-04-24Z-1166-2019Class IITalar Dome Total Ankle ProsthesisIntegra LifeSciences Corp.
2019-04-24Z-1167-2019Class IITalar Dome Total Ankle ProsthesisIntegra LifeSciences Corp.
2019-04-24Z-1168-2019Class IITalar Dome Total Ankle ProsthesisIntegra LifeSciences Corp.
2019-04-24Z-1169-2019Class IITalar Dome Total Ankle ProsthesisIntegra LifeSciences Corp.
2019-04-24Z-1170-2019Class IITalar Dome Total Ankle ProsthesisIntegra LifeSciences Corp.
2019-04-24Z-1171-2019Class IITalar Dome Total Ankle ProsthesisIntegra LifeSciences Corp.
2019-04-24Z-1172-2019Class IITalar Dome Total Ankle ProsthesisIntegra LifeSciences Corp.
2019-04-24Z-1173-2019Class IITalar Dome Total Ankle ProsthesisIntegra LifeSciences Corp.
2019-04-24Z-1174-2019Class IITalar Dome Total Ankle ProsthesisIntegra LifeSciences Corp.
2019-04-24Z-1175-2019Class IITalar Dome Total Ankle ProsthesisIntegra LifeSciences Corp.
2019-04-24Z-1176-2019Class IIProSun Onyx 32 Sli IntensiveProSun International, LLC
2019-04-24Z-1177-2019Class IIProSun V3 42 XlcProSun International, LLC
2019-04-24Z-1178-2019Class IIOlympus Diego Elite Console MDCONS 100Gyrus ACMI, Inc.
2019-04-24Z-1179-2019Class IIDiego Elite Turbinate Blades:Bipolar BladeGyrus ACMI, Inc.
2019-04-24Z-1180-2019Class IIDiego Elite Turbinate Blades Bipolar BladeGyrus ACMI, Inc.
2019-04-24Z-1181-2019Class IIDiego Elite Turbinate Blades Bipolar BladeGyrus ACMI, Inc.
2019-04-24Z-1182-2019Class IIDiego Elite Turbinate Blades Bipolar BladeGyrus ACMI, Inc.
2019-04-24Z-1183-2019Class IIDiego Elite Turbinate Blades Bipolar BladeGyrus ACMI, Inc.
2019-04-24Z-1184-2019Class IIDiego Elite Turbinate Blades Bipolar BladeGyrus ACMI, Inc.
2019-04-24Z-1185-2019Class IIDiego Elite Turbinate Blades Bipolar BladeGyrus ACMI, Inc.
2019-04-24Z-1186-2019Class IIDiego Elite Blades MonopolarGyrus ACMI, Inc.
2019-04-24Z-1187-2019Class IIDiego Elite MalleableGyrus ACMI, Inc.
2019-04-24Z-1188-2019Class IIIBIOPHEN UFH Control C2Aniara Diagnostica LLC
2019-04-24Z-1189-2019Class IIIBIOPHEN UFH Control C1Aniara Diagnostica LLC
2019-04-24Z-1190-2019Class IIIBIOPHEN LMWH Control C4Aniara Diagnostica LLC
2019-04-24Z-1191-2019Class IIObturatorMedrobotics Corporation
2019-04-24Z-1192-2019Class IIObturatorMedrobotics Corporation
2019-04-24Z-1194-2019Class IIAlbumin BCP Product Usage: ALBP is an in vitro test used for the…Roche Diagnostics Corporation
2019-04-24Z-1195-2019Class IIsyngo Lab Data Manager SystemSiemens Healthcare Diagnostics, Inc.
2019-04-24Z-1196-2019Class IIAbbott Alinity i Processing Module LN 03R65-01Abbott Gmbh & Co. KG
2019-04-24Z-1197-2019Class IIAbbott Alinity c Processing Module LN 03R67-01Abbott Gmbh & Co. KG
2019-04-24Z-1198-2019Class IIICordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The…Cordis Corporation
2019-04-24Z-1199-2019Class IIInnova IGS 630GE Healthcare, LLC
2019-04-24Z-1200-2019Class IIInnova IGS 630GE Healthcare, LLC
2019-04-24Z-1201-2019Class IIInnova IGS 6GE Healthcare, LLC
2019-04-17Z-1089-2019Class IIIntegra bioBLOCK Resorbable subtaler ImplantIntegra Limited
2019-04-17Z-1090-2019Class IIIntegra bioBLOCK Resorbable subtaler ImplantIntegra Limited
2019-04-17Z-1091-2019Class IIIntegra bioBLOCK Resorbable subtaler ImplantIntegra Limited
2019-04-17Z-1099-2019Class IISORIN Heater-Cooler System 3TLivaNova USA Inc.
2019-04-17Z-1100-2019Class IIEdwards LifesciencesEdwards Lifesciences, LLC
2019-04-17Z-1102-2019Class IIAbbott ARCHITECT c4000 Processing ModuleAbbott Laboratories, Inc
2019-04-17Z-1103-2019Class IIAbbott ARCHITECT c8000 Processing ModuleAbbott Laboratories, Inc
2019-04-17Z-1104-2019Class IIAbbott ARCHITECT c16000 Processing ModuleAbbott Laboratories, Inc
2019-04-17Z-1105-2019Class IIIImmunoassay Premium ControlsRandox Laboratories Ltd.
2019-04-17Z-1106-2019Class IIIImmunoassay Premium Plus ControlsRandox Laboratories Ltd.
2019-04-17Z-1107-2019Class IIILiquid Immunoassay Premium ControlsRandox Laboratories Ltd.
2019-04-17Z-1108-2019Class IIiTotal CR Total Knee Replacement SystemConformis, Inc.
2019-04-17Z-1109-2019Class IIElekta UnityElekta Limited
2019-04-17Z-1110-2019Class IIAquaBeam HandpiecePROCEPT BIOROBOTICS CORPORATION
2019-04-17Z-1111-2019Class IIBeaver Xstar Slit Knife 2Beaver Visitec
2019-04-17Z-1112-2019Class IIsyngoSiemens Medical Solutions USA, Inc
2019-04-17Z-1113-2019Class IIsyngoSiemens Medical Solutions USA, Inc
2019-04-17Z-1114-2019Class IIVygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888Vygon U.S.A.
2019-04-17Z-1115-2019Class IIVyon DUALSTOP White Cap used for intravascular lines Product Code:…Vygon U.S.A.
2019-04-17Z-1118-2019Class IIArrow¿ Two-Lumen Central Venous Catheterization Kit with Blue…Arrow International Inc
2019-04-17Z-1119-2019Class IIArrow¿ Two-Lumen Central Venous Catheterization Set with Blue…Arrow International Inc
2019-04-17Z-1120-2019Class IIGravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07Becton Dickinson & Company
2019-04-17Z-1121-2019Class IIGravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07Becton Dickinson & Company
2019-04-17Z-1122-2019Class IIBD Blood Collection Assembly with Male Luer LockBecton Dickinson & Company
2019-04-17Z-1123-2019Class IIExprt Precision System: Revision HipEncore Medical, Lp
2019-04-17Z-1124-2019Class IICOBAS INTEGRA 400 plus analyzer used in the following assays:…Roche Diagnostics Corporation
2019-04-17Z-1125-2019Class IIcobas c 111 with ISE analyzers analyzer used in the following assays:…Roche Diagnostics Corporation
2019-04-17Z-1126-2019Class IIULRICH Torque Limiting Handle for use with a Set Screw Driver to…ulrich medical USA Inc
2019-04-17Z-1127-2019Class IICORAIL AMT STANDARD OFFSET NECK SEGMENTDePuy Orthopaedics, Inc.
2019-04-17Z-1128-2019Class IICORAIL AMT COXA VARA NECK SEGMENTDePuy Orthopaedics, Inc.
2019-04-17Z-1129-2019Class IICORAIL AMT HIGH OFFSET NECK SEGMENTDePuy Orthopaedics, Inc.
2019-04-17Z-1130-2019Class IIAzurion FlexArmPhilips North America, LLC
2019-04-17Z-1131-2019Class IIACUVUE OASYS for ASTIGMATISM brand contact lensesJohnson & Johnson Vision Care, Inc.
2019-04-10Z-0976-2019Class Ie500 Automatic Transport VentilatorO-Two Medical Technologies, Inc.
2019-04-10Z-0977-2019Class Ie600 Automatic Transport VentilatorO-Two Medical Technologies, Inc.
2019-04-10Z-0978-2019Class Ie700 Automatic Transport VentilatorO-Two Medical Technologies, Inc.
2019-04-10Z-1074-2019Class IICELL-DYN Emerald analyzerAbbott Laboratories
2019-04-10Z-1075-2019Class IIAbbott ARCHITECT Creatine KinaseAbbott Laboratories, Inc
2019-04-10Z-1076-2019Class IIAbbott ARCHITECT Creatine KinaseAbbott Laboratories, Inc
2019-04-10Z-1077-2019Class IIThe UniCel DxI 600 and 800 Access Immunoassay SystemsBeckman Coulter Inc.
2019-04-10Z-1078-2019Class IIUniCel DxC 660iBeckman Coulter Inc.
2019-04-10Z-1079-2019Class IIiTotal Posterior StabilizedConformis, Inc.
2019-04-10Z-1080-2019Class IIIMcKesson Consult Diagnostic Immunochemical Fecal Occult Blood TestCypress Medical Products LLC
2019-04-10Z-1081-2019Class IIBiomet Small Diameter Cement Plug Inserter-SterileZimmer Biomet, Inc.
2019-04-10Z-1083-2019Class IINa¿da CL Q30 Sound ProcessorAdvanced Bionics, LLC
2019-04-10Z-1084-2019Class IINa¿da CI Q70 Sound ProcessorAdvanced Bionics, LLC
2019-04-10Z-1085-2019Class IINa¿da CI Q90 Sound ProcessorAdvanced Bionics, LLC
2019-04-10Z-1086-2019Class IIBiomet RingLoc Hip System Self-Tapping Bone Screw 6Zimmer Biomet, Inc.
2019-04-10Z-1087-2019Class IIBiomet RingLoc Hip System Self-Tapping Bone Screw 6Zimmer Biomet, Inc.
2019-04-10Z-1088-2019Class IIIMicro Knife 5Beaver Visitec
2019-04-03Z-0986-2019Class ICardiohelp Emergency DriveMaquet Cardiovascular Us Sales, Llc
2019-04-03Z-1041-2019Class IIKendall SCD Express Sterile SleevesCOVIDIEN LLC
2019-04-03Z-1042-2019Class IIJOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2Smith & Nephew, Inc.
2019-04-03Z-1043-2019Class IIJOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4Smith & Nephew, Inc.
2019-04-03Z-1044-2019Class IIJOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6Smith & Nephew, Inc.
2019-04-03Z-1045-2019Class IIJOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8Smith & Nephew, Inc.
2019-04-03Z-1046-2019Class IIAvitus¿ Bone Harvester w/ Filter InsertAvitus Orthopaedics, Inc.
2019-04-03Z-1047-2019Class IIAvitus¿ Bone Harvester w/ Filter InsertAvitus Orthopaedics, Inc.
2019-04-03Z-1048-2019Class IILW Scientific ZIP IQ PCV CentrifugeLW Scientific, Inc.
2019-04-03Z-1049-2019Class IILW Scientific ZIP IQ Combo CentrifugeLW Scientific, Inc.
2019-04-03Z-1050-2019Class IILW Scientific ZIP IQ Combo CentrifugeLW Scientific, Inc.

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