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Medical device recalls reported in 2016

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ReportedRecallClassProductFirm
2016-10-26Z-0287-2017Class IIMohs Closer PackWindstone Medical Packaging, Inc.
2016-10-26Z-0288-2017Class IIPort Access KitWindstone Medical Packaging, Inc.
2016-10-26Z-0289-2017Class IIVari-Safe Injection Needle US endoscopy 5976 Heisley Road MentorUS Endoscopy Group Inc
2016-10-26Z-0290-2017Class IIRTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal RodRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
2016-10-26Z-0291-2017Class IIPhilips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS…Philips Electronics North America Corporation
2016-10-26Z-0292-2017Class IIPhilips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hoppingPhilips Electronics North America Corporation
2016-10-26Z-0293-2017Class IIPhilips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802Philips Electronics North America Corporation
2016-10-26Z-0294-2017Class IIFusion WorkstationMerge Healthcare, Inc.
2016-10-26Z-0295-2017Class IIEndoscopic Articulating Linear CutterEthicon Endo-Surgery Inc
2016-10-26Z-0296-2017Class IIEndoscopic Articulating Linear CutterEthicon Endo-Surgery Inc
2016-10-19Z-0006-2017Class IHeartWare Ventricular Assist SystemHeartWare, Inc
2016-10-19Z-0056-2017Class IIThe Medix NatalCare LX Intensive Care IncubatorNatus Medical Incorporated
2016-10-19Z-0057-2017Class IIIThe Better-Bladder With 14" ID tubingCirculatory Technology Inc
2016-10-19Z-0058-2017Class IITeleflex Percuaneous SolutionsTeleflex Medical
2016-10-19Z-0059-2017Class IITeleflex Percuaneous SolutionsTeleflex Medical
2016-10-19Z-0060-2017Class IIStryker Orthopaedics Universal Acetabular Cup Positioner/ImpactorStryker Howmedica Osteonics Corp.
2016-10-19Z-0061-2017Class IISymbia SSiemens Medical Solutions USA, Inc.
2016-10-19Z-0062-2017Class IISymbia T Series SPECT + CT Product Usage 1) SPECT: To Detect or image…Siemens Medical Solutions USA, Inc.
2016-10-19Z-0063-2017Class IIBlood Pressure Monitor UA-767PBT-Ci for small cuffA & D Enginering Inc
2016-10-19Z-0064-2017Class IITransMotion MedicalWinco Mfg., LLC
2016-10-19Z-0065-2017Class IITransMotion MedicalWinco Mfg., LLC
2016-10-19Z-0066-2017Class IITransMotion MedicalWinco Mfg., LLC
2016-10-19Z-0067-2017Class IIThe Introes Pocket Bougie is an endotracheal tube introducerBrathwaites Oliver Medical
2016-10-19Z-0068-2017Class IIBioSentry Tract Sealant SystemSurgical Specialties Mexico S DE RL DE CV
2016-10-19Z-0069-2017Class IIVCardinal Health 200, LLC
2016-10-19Z-0070-2017Class IIMedtronic Navigation O-arm O2 Surgical Imaging System Product Catalog…Medtronic Navigation, Inc.-Littleton
2016-10-19Z-0071-2017Class IIOEC Brivo 715 PrimeGE OEC Medical Systems, Inc
2016-10-19Z-0072-2017Class IIADVIA Centaur XPT Immunoassay SystemSiemens Healthcare Diagnostics, Inc.
2016-10-19Z-0073-2017Class IIFujifilm Synapse PACSFujifilm Medical Systems U.S.A., Inc.
2016-10-19Z-0074-2017Class IIBanyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x CannulaBanyan Medical, LLC
2016-10-19Z-0075-2017Class IIBanyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ SideportBanyan Medical, LLC
2016-10-19Z-0076-2017Class IIMonaco RTP System The Monaco system is used to make treatment plans…Elekta, Inc.
2016-10-19Z-0077-2017Class IIVarian Head FrameVarian Medical Systems, Inc.
2016-10-19Z-0078-2017Class IITheraSphereBiocompatibles U.K., Ltd.
2016-10-19Z-0079-2017Class IIRadiation Therapy Treatment Planning SystemRAYSEARCH LABORATORIES AB
2016-10-19Z-0080-2017Class IIZero-Gravity Radiation Protection System Radiology Personnel…Contour Fabricators Inc
2016-10-19Z-0081-2017Class IISIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgMSiemens Healthcare Diagnostics, Inc.
2016-10-19Z-0082-2017Class IISIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgMSiemens Healthcare Diagnostics, Inc.
2016-10-19Z-0083-2017Class IIPhoenix Recon Soft Tissue Sleeve GuideZimmer Biomet, Inc.
2016-10-19Z-0084-2017Class IIPhoenix Recon Targeting Arm GuideZimmer Biomet, Inc.
2016-10-19Z-0085-2017Class IICONCEPT HEATWAVE Electrode 130 mm x 2ConMed Corporation
2016-10-12Z-0001-2017Class IIICDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as…Terumo Cardiovascular Systems Corporation
2016-10-12Z-0002-2017Class IIMerit Inflation Syringe KitMerit Medical Systems, Inc.
2016-10-12Z-0003-2017Class IIVanguard 360 Revision Knee System Knee prosthesesZimmer Biomet, Inc.
2016-10-12Z-0007-2017Class I0Baxter Corporation Englewood
2016-10-12Z-0008-2017Class IIThermo Scientific QMS Everolimus AssayMicrogenics Corporation
2016-10-12Z-0009-2017Class IIBrilliance 64 CT Model Number 728231 Product Usage: Computed…Philips Medical Systems
2016-10-12Z-0010-2017Class IIIngenuity Core Model Number 728321 Product Usage: Computed Tomography…Philips Medical Systems
2016-10-12Z-0011-2017Class IIIngenuity Core 128 Model Number 728323 Product Usage: Computed…Philips Medical Systems
2016-10-12Z-0012-2017Class IIIngenuity CT Model Number 728326 Product Usage: Computed Tomography…Philips Medical Systems
2016-10-12Z-0013-2017Class IIMultix Fusion Stationary X-Ray System Product Usage: The Multix…Siemens Medical Solutions USA, Inc
2016-10-12Z-0014-2017Class IIMultix Fusion VA10 Product Usage: The Multix Fusion VA10 system is a…Siemens Medical Solutions USA, Inc
2016-10-12Z-0015-2017Class IIYSIO Max Product Usage: The Ysio Max is a radiographic system used in…Siemens Medical Solutions USA, Inc
2016-10-12Z-0016-2017Class IIPanoramic X-ray Model PC-1000Panoramic Rental Corp.
2016-10-12Z-0017-2017Class IIZenostar MT Color Impulse blueIvoclar Vivadent, Inc.
2016-10-12Z-0018-2017Class IIZenostar MT Color Impulse brownIvoclar Vivadent, Inc.
2016-10-12Z-0019-2017Class IIZenostar MT Color Impulse greyIvoclar Vivadent, Inc.
2016-10-12Z-0020-2017Class IIZenostar MT Color Impulse violetIvoclar Vivadent, Inc.
2016-10-12Z-0021-2017Class IIZenostar MT Color A1 60mlIvoclar Vivadent, Inc.
2016-10-12Z-0022-2017Class IIZenostar MT Color A2 60mlIvoclar Vivadent, Inc.
2016-10-12Z-0023-2017Class IIZenostar MT Color A3 60mlIvoclar Vivadent, Inc.
2016-10-12Z-0024-2017Class IIZenostar MT Color A3Ivoclar Vivadent, Inc.
2016-10-12Z-0025-2017Class IIZenostar MT Color A4 60mlIvoclar Vivadent, Inc.
2016-10-12Z-0026-2017Class IIZenostar MT Color B1 60mlIvoclar Vivadent, Inc.
2016-10-12Z-0027-2017Class IIZenostar MT Color B2 60mlIvoclar Vivadent, Inc.
2016-10-12Z-0028-2017Class IIZenostar MT Color B3 60mlIvoclar Vivadent, Inc.
2016-10-12Z-0029-2017Class IIZenostar MT Color B4 60mlIvoclar Vivadent, Inc.
2016-10-12Z-0030-2017Class IIZenostar MT Color C1 60mlIvoclar Vivadent, Inc.
2016-10-12Z-0031-2017Class IIZenostar MT Color C2 60ml artIvoclar Vivadent, Inc.
2016-10-12Z-0032-2017Class IIZenostar MT Color C3 60mlIvoclar Vivadent, Inc.
2016-10-12Z-0033-2017Class IIZenostar MT Color C4 60mlIvoclar Vivadent, Inc.
2016-10-12Z-0034-2017Class IIZenostar MT Color D2 60mlIvoclar Vivadent, Inc.
2016-10-12Z-0035-2017Class IIZenostar MT Color D3 60mlIvoclar Vivadent, Inc.
2016-10-12Z-0036-2017Class IIZenostar MT Color D4 60mlIvoclar Vivadent, Inc.
2016-10-12Z-0037-2017Class IIZenostar MT Color Impulse orangeIvoclar Vivadent, Inc.
2016-10-12Z-0038-2017Class IIRayStation 2RAYSEARCH LABORATORIES AB
2016-10-12Z-0039-2017Class IIDimension Vista¿ CalciumSiemens Healthcare Diagnostics, Inc.
2016-10-12Z-0040-2017Class IIMobile Column TruSystem 7500Trumpf Medical Systems, Inc.
2016-10-12Z-0041-2017Class IIStationary Column TruSystem 7599Trumpf Medical Systems, Inc.
2016-10-12Z-0042-2017Class IIFloor Mounting Column TS 7500 UTrumpf Medical Systems, Inc.
2016-10-12Z-0043-2017Class IIOperating Table TruSystem 7000 UTrumpf Medical Systems, Inc.
2016-10-12Z-0045-2017Class IIROI-A Anterior Delivery DeviceLDR Spine USA, Inc.
2016-10-12Z-0046-2017Class IIToshiba America Medical SystemsToshiba American Medical Systems Inc
2016-10-12Z-0047-2017Class IIToshiba America Medical SystemsToshiba American Medical Systems Inc
2016-10-12Z-0048-2017Class IIToshiba America Medical SystemsToshiba American Medical Systems Inc
2016-10-12Z-0049-2017Class IIToshiba America Medical SystemsToshiba American Medical Systems Inc
2016-10-12Z-0050-2017Class IIIgE Calibrator SeriesRandox Laboratories Ltd.
2016-10-12Z-0051-2017Class IIMicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo…Argon Medical Devices, Inc
2016-10-12Z-2833-2016Class IITriFoillmaging Triumph/Triumph II Research CT scannersNorthridge Tri-Modality Imaging,
2016-10-12Z-2905-2016Class IIIntegra Straight Ventricular Catheter F8Integra LifeSciences Corp.
2016-10-12Z-2906-2016Class IICUSA Dissectron Fingertip Laparoscopic CannulaIntegra LifeSciences Corp.
2016-10-12Z-2907-2016Class IIIntegral Lumbar Drainage SetIntegra LifeSciences Corp.
2016-10-12Z-2908-2016Class IIIntegra Drainage Accessory KitsIntegra LifeSciences Corp.
2016-10-12Z-2909-2016Class IIIntegra Ventricular Catheter Accessory KitIntegra LifeSciences Corp.
2016-10-12Z-2910-2016Class IIIntegra Lumbar Drainage SetIntegra LifeSciences Corp.
2016-10-12Z-2911-2016Class IIWalrus Arterial Embolectomy Catheter The arterial embolectomy…Arrow International Inc
2016-10-12Z-2912-2016Class IIISiemens RAPIDPoint 400 Measurement Cartridge Siemens SMN…Siemens Healthcare Diagnostics Inc
2016-10-12Z-2913-2016Class IIISiemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers:…Siemens Healthcare Diagnostics Inc
2016-10-12Z-2914-2016Class IICT3PlusNew Star Lasers, Inc.
2016-10-12Z-2915-2016Class IIVariaBreezeNew Star Lasers, Inc.
2016-10-12Z-2916-2016Class IIReNewNew Star Lasers, Inc.
2016-10-12Z-2917-2016Class IIBLUE IMPERVIOUS GOWN WITH THUMBHOOKSCardinal Health
2016-10-12Z-2918-2016Class IIIArthrex Suture WasherArthrex, Inc.
2016-10-05Z-2783-2016Class ILight Adaptor for Small Battery Drive and Small Battery Drive IIThe Anspach Effort, Inc.
2016-10-05Z-2784-2016Class IAdaptor for Small Battery Drive and Small Battery Drive IIThe Anspach Effort, Inc.
2016-10-05Z-2876-2016Class IIARTISTESiemens Medical Solutions USA, Inc
2016-10-05Z-2877-2016Class IIPRIMUSSiemens Medical Solutions USA, Inc
2016-10-05Z-2878-2016Class IISyngo RT TherapistSiemens Medical Solutions USA, Inc
2016-10-05Z-2879-2016Class IIAlaris Syringe Module Model 8110 with software version 9CareFusion 303, Inc.
2016-10-05Z-2880-2016Class IITRUEread Blood Glucose Test StripsTrividia Health
2016-10-05Z-2881-2016Class IITRUEread Blood Glucose Test StripsTrividia Health
2016-10-05Z-2882-2016Class IITRUEread Blood Glucose Test StripsTrividia Health
2016-10-05Z-2883-2016Class IITRUEread Blood Glucose Test StripsTrividia Health
2016-10-05Z-2884-2016Class IIDRI Salicylate Serum Tox AssayMicrogenics Corporation
2016-10-05Z-2885-2016Class IISpacelabs Healthcare Xhibit Central StationSpacelabs Healthcare Inc
2016-10-05Z-2886-2016Class IISpacelabs Healthcare Xhibit Telemetry ReceiverSpacelabs Healthcare Inc
2016-10-05Z-2887-2016Class IIR&D SystemsR & D Systems, Inc.
2016-10-05Z-2888-2016Class IISpiegelberg Brain Pressure Monitoring System Probe 3PNSpiegelberg Gmbh & Co. KG
2016-10-05Z-2889-2016Class IIETHICON MERSILENE" TapeEthicon, Inc.
2016-10-05Z-2890-2016Class IIThe EKOS cart has the catalog number 700-60101EKOS Corporation
2016-10-05Z-2891-2016Class IISyngoSiemens Medical Solutions USA, Inc
2016-10-05Z-2892-2016Class IISyngoSiemens Medical Solutions USA, Inc
2016-10-05Z-2893-2016Class IIZyno Medical Administration SetZyno Medical LLC
2016-10-05Z-2894-2016Class IIZyno Medical Administration SetZyno Medical LLC
2016-10-05Z-2895-2016Class IIZyno Medical Administration SetZyno Medical LLC
2016-10-05Z-2896-2016Class IIZyno Medical Administration Set SterileZyno Medical LLC
2016-10-05Z-2897-2016Class IIBruxZir ShadedPrismatik Dentalcraft, Inc
2016-10-05Z-2898-2016Class IICareLink iPro Version 1Medtronic Inc.
2016-10-05Z-2899-2016Class IISiemens ADVIA Centaur¿ Calibrator USiemens Healthcare Diagnostics, Inc
2016-10-05Z-2900-2016Class IIAQUIOS CL Flow CytometerBeckman Coulter Inc.
2016-09-28Z-2835-2016Class IIFPS 35mm x 3Ortho Solutions Inc
2016-09-28Z-2836-2016Class IISealapex XpressOrmco/Sybronendo
2016-09-28Z-2837-2016Class IIG1 Dissection ToolThe Anspach Effort, Inc.
2016-09-28Z-2838-2016Class IIG1 Dissection ToolThe Anspach Effort, Inc.
2016-09-28Z-2839-2016Class IIG1 Dissection ToolThe Anspach Effort, Inc.
2016-09-28Z-2840-2016Class IIG1 Dissection ToolThe Anspach Effort, Inc.
2016-09-28Z-2841-2016Class IIIG1Siemens Healthcare Diagnostics, Inc.
2016-09-28Z-2842-2016Class IIHeartStart MRx Monitor/Defibrillator Models: M3535A and M3536APhilips Electronics North America Corporation
2016-09-28Z-2843-2016Class II3OrthoPediatrics Corp
2016-09-28Z-2844-2016Class II3OrthoPediatrics Corp
2016-09-28Z-2845-2016Class II3I OSSEOTITE CERTAIN DENTAL IMPLANTSBiomet 3i, LLC
2016-09-28Z-2846-2016Class IIBroselow/HinkleCarefusion 2200 Inc
2016-09-28Z-2847-2016Class IIBroselow/HinkleCarefusion 2200 Inc
2016-09-28Z-2848-2016Class IIRENASYS Sterile Transparent Film and all the RENASYS Dressing kits…Smith & Nephew, Inc.
2016-09-28Z-2849-2016Class IITriMed Semi-Tubular PlateTrimed Inc
2016-09-28Z-2850-2016Class IIISage In-Vitro Fertilization- CSCCooperSurgical, Inc.
2016-09-28Z-2851-2016Class IIISage In-Vitro Fertilization- CSCCooperSurgical, Inc.
2016-09-28Z-2852-2016Class IISyngoSiemens Medical Solutions USA, Inc
2016-09-28Z-2853-2016Class IISyngoSiemens Medical Solutions USA, Inc
2016-09-28Z-2854-2016Class IIEkoSonic Endovascular Devices EKOS Intelligent Drug Delivery CatheterEKOS Corporation
2016-09-28Z-2855-2016Class IISENSAR Foldable IOL with OptiEdge DesignAbbott Medical Optics Inc. (AMO)
2016-09-28Z-2856-2016Class IITECNIS Multifocal 1-Piece Intraocular LensAbbott Medical Optics Inc. (AMO)
2016-09-28Z-2857-2016Class IITECNIS Symfony Extended Range of Vision IOLAbbott Medical Optics Inc. (AMO)
2016-09-28Z-2858-2016Class IITECNIS 1-Piece IOLAbbott Medical Optics Inc. (AMO)
2016-09-28Z-2859-2016Class IITECNIS OptiBlue 1-Piece Intraocular LensAbbott Medical Optics Inc. (AMO)
2016-09-28Z-2860-2016Class IISENSAR 1-Piece IOLAbbott Medical Optics Inc. (AMO)
2016-09-28Z-2861-2016Class IITECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery SystemAbbott Medical Optics Inc. (AMO)
2016-09-28Z-2862-2016Class IITECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery…Abbott Medical Optics Inc. (AMO)
2016-09-28Z-2863-2016Class IITECNIS Multifocal Foldable Acrylic Intraocular LensAbbott Medical Optics Inc. (AMO)
2016-09-28Z-2864-2016Class IIAMO TECNIS CL Foldable Silicone IOL with OptiEdge DesignAbbott Medical Optics Inc. (AMO)
2016-09-28Z-2865-2016Class IIMerge Cardio softwareMerge Healthcare, Inc.
2016-09-28Z-2866-2016Class IISt¿ckert S5 SystemSorin Group USA, Inc.
2016-09-28Z-2867-2016Class IIPhilips Expression Information PortalInvivo Corporation
2016-09-28Z-2868-2016Class IIPHS Spinal Tray 24G Gertie MarxIntegra LifeSciences Corp. d.b.a. Integra Pain Management
2016-09-28Z-2869-2016Class IISertera Biopsy DeviceHologic, Inc
2016-09-28Z-2870-2016Class IIMED 5223Global Healthcare Inc
2016-09-28Z-2871-2016Class IICADstream softwareMerge Healthcare, Inc.
2016-09-28Z-2872-2016Class IIMcKesson RadiologyMckesson Medical Imaging Group
2016-09-28Z-2873-2016Class IILifeCare PCA Infusion System with Hospira MedNet SoftwareHospira Inc.
2016-09-28Z-2874-2016Class IILifeCare PCA 3Hospira Inc.
2016-09-28Z-2875-2016Class IIPentax Video Bronchoscope Designed to be used with a Pentax Video…Pentax of America Inc
2016-09-21Z-2770-2016Class IIFluorocell PLT reagentSysmex America Inc
2016-09-21Z-2771-2016Class IICatheterArrow International Inc
2016-09-21Z-2772-2016Class IICatherArrow International Inc
2016-09-21Z-2773-2016Class IICatheterArrow International Inc
2016-09-21Z-2774-2016Class IICatheterArrow International Inc
2016-09-21Z-2775-2016Class IIEndura MD Mass Spectrometer u using software versions Endura MD…Thermo Finnigan LLC
2016-09-21Z-2776-2016Class IICARTO 3 EP Navigation System and AccessoriesBiosense Webster, Inc.
2016-09-21Z-2777-2016Class IIIntegra Meshed Dermal Regeneration Template 5 cmx 5 cmIntegra LifeSciences Corporation
2016-09-21Z-2778-2016Class IIILDX Optical Check CassettesAlere San Diego, Inc.
2016-09-21Z-2779-2016Class IIIVIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNPBiomerieux France Chemin De L'Or
2016-09-21Z-2780-2016Class IIArtoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders…Mentor Texas, LP.
2016-09-21Z-2781-2016Class IICPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders…Mentor Texas, LP.
2016-09-21Z-2782-2016Class IIITrinity Biotech Captia Measles IgMClark Laboratories, Inc. (dba,Trinity Biotech USA)
2016-09-21Z-2785-2016Class IIGREER 2 ML Sterile Empty Vials 2-13 vial 25 eaAllergy Laboratories, Inc.
2016-09-21Z-2786-2016Class IIAccuLIF PL 6-9mm x 11mm x 27mm x 8 CageHowmedica Osteonics Corp.
2016-09-21Z-2787-2016Class IIAccuLIF PL 8-12mm x 11mm x 27mm x 8 CageHowmedica Osteonics Corp.
2016-09-21Z-2788-2016Class IIAccuLIF PL 10-16mm x 11mm x 27mm x 8 CageHowmedica Osteonics Corp.
2016-09-21Z-2789-2016Class IIStryker Orthopaedics Patella Assembly InstrumentStryker Howmedica Osteonics Corp.
2016-09-21Z-2790-2016Class IIHospira MedNet Medication Management Suite softwareHospira Inc., A Pfizer Company
2016-09-21Z-2791-2016Class IISupracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is…Stryker Howmedica Osteonics Corp.
2016-09-21Z-2792-2016Class IIFemoral NailStryker Howmedica Osteonics Corp.
2016-09-21Z-2793-2016Class IISyngo Plaza picture archiving and communication systemSiemens Medical Solutions USA, Inc
2016-09-21Z-2794-2016Class IISyngoSiemens Medical Solutions USA, Inc
2016-09-21Z-2795-2016Class IIT2Candida¿CartridgesT2 Biosystems Inc
2016-09-21Z-2796-2016Class IIRadSuite softwareMerge Healthcare, Inc.
2016-09-21Z-2797-2016Class IISiemens RAPIDPoint¿ 400 Blood Gas Analyzer Siemens Material NumberSiemens Healthcare Diagnostics Inc
2016-09-21Z-2798-2016Class IISiemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material…Siemens Healthcare Diagnostics Inc
2016-09-21Z-2799-2016Class IISiemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material NumberSiemens Healthcare Diagnostics Inc
2016-09-21Z-2800-2016Class IISiemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material NumberSiemens Healthcare Diagnostics Inc

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