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Medical device recalls reported in 2020

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ReportedRecallClassProductFirm
2020-04-01Z-1555-2020Class IImager II 5F Angiographic CathetersBoston Scientific Corporation
2020-04-01Z-1556-2020Class IIPrecision Xtra Blood Glucose & Ketone Monitoring SystemAbbott Diabetes Care, Inc.
2020-04-01Z-1557-2020Class IIOptium EZ Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.
2020-04-01Z-1558-2020Class IIFreeStyle Precision H Blood Glucose and Ketone Monitoring SystemAbbott Diabetes Care, Inc.
2020-04-01Z-1559-2020Class IIIntellijoint Navigation SystemIntellijoint Surgical, Inc.
2020-04-01Z-1560-2020Class IIDexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4…Dexcom Inc
2020-04-01Z-1561-2020Class IIDexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM…Dexcom Inc
2020-04-01Z-1562-2020Class IIDexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM…Dexcom Inc
2020-04-01Z-1563-2020Class IIVNS Therapy ProgrammerLivaNova USA Inc
2020-04-01Z-1564-2020Class IICaptus 4000e Thyroid Uptake SystemCapintec Inc
2020-04-01Z-1565-2020Class IIPericardiocentesis SetCook Inc.
2020-04-01Z-1566-2020Class IISpectrum Central Venous Catheter TrayCook Inc.
2020-04-01Z-1568-2020Class IIEncina HA Femoral StemSignature Orthopaedics Europe Ltd
2020-04-01Z-1569-2020Class IISkytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen BracketSkytron, Div. The KMW Group, Inc
2020-04-01Z-1570-2020Class II1Bard Peripheral Vascular Inc
2020-04-01Z-1571-2020Class II1Bard Peripheral Vascular Inc
2020-04-01Z-1572-2020Class II1Bard Peripheral Vascular Inc
2020-04-01Z-1573-2020Class II1Bard Peripheral Vascular Inc
2020-04-01Z-1574-2020Class II1Bard Peripheral Vascular Inc
2020-04-01Z-1575-2020Class IIBardPort Titanium Implantable Port with Attachable 9Bard Peripheral Vascular Inc
2020-04-01Z-1576-2020Class IIBardPort MBard Peripheral Vascular Inc
2020-04-01Z-1577-2020Class IIBardPort MBard Peripheral Vascular Inc
2020-04-01Z-1578-2020Class II1Bard Peripheral Vascular Inc
2020-04-01Z-1579-2020Class IIPowerFlow Implatable Apheresis IV Port with attachable 9Bard Peripheral Vascular Inc
2020-04-01Z-1580-2020Class IILN 3R70-01Abbott Gmbh & Co. KG
2020-04-01Z-1581-2020Class IIMiniMed Insulin PumpMedtronic MiniMed
2020-04-01Z-1582-2020Class IIMiniMed Paradigm Model 511 Insulin PumpMedtronic MiniMed
2020-04-01Z-1583-2020Class IIMiniMed Paradigm 512 Insulin pumpMedtronic MiniMed
2020-04-01Z-1584-2020Class IIMiniMed Paradigm Insulin pumpMedtronic MiniMed
2020-04-01Z-1585-2020Class IIMedtronic MiniMed Paradigm Insulin pumpMedtronic MiniMed
2020-04-01Z-1586-2020Class IIMedtronic MiniMed Paradigm Insulin pumpMedtronic MiniMed
2020-04-01Z-1587-2020Class IIMedtronic MiniMed Paradigm Insulin pumpMedtronic MiniMed
2020-04-01Z-1588-2020Class IIMedtronic MiniMed Paradigm Insulin pumpMedtronic MiniMed
2020-04-01Z-1589-2020Class IIMedtronic MiniMed Paradigm Insulin pumpMedtronic MiniMed
2020-04-01Z-1590-2020Class IIMedtronic MiniMed Paradigm Insulin pumpMedtronic MiniMed
2020-04-01Z-1591-2020Class IIMedtronic MiniMed Paradigm Insulin pumpMedtronic MiniMed
2020-04-01Z-1592-2020Class IIMedtronic MiniMed Paradigm Insulin pumpMedtronic MiniMed
2020-04-01Z-1593-2020Class IIMedtronic MiniMed Paradigm Insulin pumpMedtronic MiniMed
2020-04-01Z-1594-2020Class IIMedtronic MiniMed Paradigm Insulin pumpMedtronic MiniMed
2020-04-01Z-1595-2020Class IIMedtronic MiniMed Paradigm Veo Insulin pumpMedtronic MiniMed
2020-04-01Z-1596-2020Class IIMedtronic MiniMed Paradigm Veo Insulin pumpMedtronic MiniMed
2020-04-01Z-1597-2020Class IIMOSAIQElekta Impac Software
2020-04-01Z-1598-2020Class IIRayStation standalone software treatment planning systemRAYSEARCH LABORATORIES AB
2020-04-01Z-1599-2020Class IIAtellica CH Ethyl AlcoholSiemens Healthcare Diagnostics, Inc.
2020-03-25Z-1474-2020Class ICME America BodyGuard Infusion Pump SystemCME America, LLC
2020-03-25Z-1478-2020Class IIColumbus R/PS TIBAesculap Implant Systems LLC
2020-03-25Z-1479-2020Class IICOLUMBUS CR/PS TIBAesculap Implant Systems LLC
2020-03-25Z-1480-2020Class IICOLUMBUS CRA/PSA TIBAesculap Implant Systems LLC
2020-03-25Z-1481-2020Class IIAS COLUMBUS CR/PS TIBAesculap Implant Systems LLC
2020-03-25Z-1482-2020Class IICOLUMBUS REV F TIBIA OFFSET CEMENTEDAesculap Implant Systems LLC
2020-03-25Z-1483-2020Class IITeleflex Pilling Aortic PunchDeroyal Industries, Inc. Lafollette
2020-03-25Z-1484-2020Class IITRUMATCH OrthognathicMaterialise N.V.
2020-03-25Z-1485-2020Class IITRUMATCH OrthognathicsMaterialise N.V.
2020-03-25Z-1486-2020Class IIAllura Exper FD SeriesPhilips North America, LLC
2020-03-25Z-1487-2020Class IIIntegris Allura 15 & 12Philips North America, LLC
2020-03-25Z-1488-2020Class IIIntegris Allura 9Philips North America, LLC
2020-03-25Z-1489-2020Class IIMultiDiagnost ElevaPhilips North America, LLC
2020-03-25Z-1490-2020Class IIOmniDiagnost Eleva System codes 708028 708027Philips North America, LLC
2020-03-25Z-1491-2020Class IIPoly G Integris H5000Philips North America, LLC
2020-03-25Z-1492-2020Class IIUroDiagnost ElevaPhilips North America, LLC
2020-03-25Z-1493-2020Class IIAllura CV20Philips North America, LLC
2020-03-25Z-1494-2020Class IICardio Vascular-Allura CentronPhilips North America, LLC
2020-03-25Z-1495-2020Class IIArtis Q BiplaneSiemens Medical Solutions USA, Inc
2020-03-25Z-1496-2020Class IIArtis QSiemens Medical Solutions USA, Inc
2020-03-25Z-1497-2020Class IIArtis zee BiplaneSiemens Medical Solutions USA, Inc
2020-03-25Z-1498-2020Class IILivaNova Heater-Cooler System 3TLivaNova USA Inc.
2020-03-25Z-1499-2020Class IIHeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536APhilips North America, LLC
2020-03-25Z-1500-2020Class IIRheumatoid FactorThe Binding Site Group, Ltd.
2020-03-25Z-1501-2020Class IIYsioSiemens Medical Solutions USA, Inc
2020-03-25Z-1502-2020Class IIAGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a…Agfa N.V.
2020-03-25Z-1503-2020Class IID-0012 3COR 12MM DISTRACTION SCREWSTeDan Surgical Innovations LLC
2020-03-25Z-1504-2020Class IID-0014 3COR 14MM DISTRACTION SCREWSTeDan Surgical Innovations LLC
2020-03-25Z-1505-2020Class IIDS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILETeDan Surgical Innovations LLC
2020-03-25Z-1506-2020Class IIDS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILETeDan Surgical Innovations LLC
2020-03-25Z-1507-2020Class IILEGION PS High Flex XLPE size 5-6 9mm Articular InsertSmith & Nephew, Inc.
2020-03-25Z-1508-2020Class IIStrykerStryker Corporation
2020-03-25Z-1509-2020Class IIStrykerStryker Corporation
2020-03-25Z-1510-2020Class IILow Profile ScrewArthrex, Inc.
2020-03-25Z-1511-2020Class IIBoston ScientificBoston Scientific Corporation
2020-03-25Z-1512-2020Class IIBoston ScientificBoston Scientific Corporation
2020-03-25Z-1513-2020Class IIIMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21Siemens Healthcare Diagnostics, Inc.
2020-03-25Z-1514-2020Class IIIMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22Siemens Healthcare Diagnostics, Inc.
2020-03-25Z-1515-2020Class IICustom procedure trays containing medical components needed to…Avid Medical, Inc.
2020-03-25Z-1516-2020Class IICustom procedure trays containing medical components needed to…Avid Medical, Inc.
2020-03-25Z-1517-2020Class IICustom procedure trays containing medical components needed to…Avid Medical, Inc.
2020-03-25Z-1518-2020Class IICustom procedure trays containing medical components needed to…Avid Medical, Inc.
2020-03-25Z-1519-2020Class IICustom procedure trays containing medical components needed to…Avid Medical, Inc.
2020-03-25Z-1520-2020Class IICustom procedure trays containing medical components needed to…Avid Medical, Inc.
2020-03-25Z-1521-2020Class IICustom procedure trays containing medical components needed to…Avid Medical, Inc.
2020-03-25Z-1522-2020Class IICustom procedure trays containing medical components needed to…Avid Medical, Inc.
2020-03-25Z-1523-2020Class IICustom procedure trays containing medical components needed to…Avid Medical, Inc.
2020-03-25Z-1524-2020Class IIMedtronic CareLink 2090 ProgrammerMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2020-03-25Z-1525-2020Class IIMedtronic CareLink Encore 29901 ProgrammerMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2020-03-25Z-1526-2020Class IIOsteoSelect Demineralized Bone MatrixXTANT MEDICAL INC
2020-03-18Z-1427-2020Class IHeartWare HVAD System Battery Charger The HeartWare HVAD System is…Heartware, Inc.
2020-03-18Z-1428-2020Class IHeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD…Heartware, Inc.
2020-03-18Z-1442-2020Class IBodyGuard Microset REF A120-003XYVACME America, LLC
2020-03-18Z-1449-2020Class IIMedtronic Simulus 750 Flexible Ring/Band Accessory KitMedtronic CoreValve LLC
2020-03-18Z-1450-2020Class IIMedtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size…Medtronic CoreValve LLC
2020-03-18Z-1451-2020Class IIFilmArray GastronintestinalBioFire Diagnostics, LLC
2020-03-18Z-1452-2020Class IIConcerto & Basic Shower TrollyARJOHUNTLEIGH POLSKA Sp. z.o.o.
2020-03-18Z-1453-2020Class IIMonoject 3mL Syringe with Hypodermic Safety NeedleCardinal Health 200, LLC
2020-03-18Z-1454-2020Class IIMonoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005Cardinal Health 200, LLC
2020-03-18Z-1455-2020Class IIMonoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558Cardinal Health 200, LLC
2020-03-18Z-1456-2020Class IIMonoject Bluntfill with FilterCardinal Health 200, LLC
2020-03-18Z-1457-2020Class IIEconocare Plus Overlay Item: 1025ECEHOB, Inc.
2020-03-18Z-1458-2020Class IINextra Hammertoe Correction System-4Nextremity Solutions
2020-03-18Z-1459-2020Class IIBraemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center…Braemar Manufacturing, LLC
2020-03-18Z-1460-2020Class IIBraemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center…Braemar Manufacturing, LLC
2020-03-18Z-1461-2020Class IIRandox Laboratories LtdResponse Biomedical Corp.
2020-03-18Z-1462-2020Class IIRayStation/RayPlan 8ARAYSEARCH LABORATORIES AB
2020-03-18Z-1463-2020Class IIRayStation/RayPlan 8A Service Pack 1RAYSEARCH LABORATORIES AB
2020-03-18Z-1464-2020Class IIRayStation/RayPlan 8BRAYSEARCH LABORATORIES AB
2020-03-18Z-1465-2020Class IIRayStation/RayPlan 8B Service Pack 1RAYSEARCH LABORATORIES AB
2020-03-18Z-1466-2020Class IIRayStation/RayPlan 8B Service Pack 2RAYSEARCH LABORATORIES AB
2020-03-18Z-1467-2020Class IIRayStation/RayPlan 9ARAYSEARCH LABORATORIES AB
2020-03-18Z-1468-2020Class IIRayStation/RayPlan 9BRAYSEARCH LABORATORIES AB
2020-03-18Z-1469-2020Class IIVaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay…The Binding Site Group, Ltd.
2020-03-18Z-1470-2020Class IIINeuraGen Nerve GuideIntegra LifeSciences Corp.
2020-03-18Z-1471-2020Class IIGlideScope Video LaryngoscopeVerathon, Inc.
2020-03-18Z-1472-2020Class IIPedicle ScrewsMedicrea International
2020-03-18Z-1473-2020Class IIIliac ScrewsMedicrea International
2020-03-18Z-1475-2020Class IIGetinge 88-Series-washer disinfectors intended for cleaningMaquet Cardiovascular Us Sales, Llc
2020-03-18Z-1476-2020Class IIQIAGEN Rotor Gene Q Software version 2Qiagen Sciences LLC
2020-03-18Z-1477-2020Class IICordis POWERFLEX P3Cordis Corporation
2020-03-11Z-1359-2020Class ICareFusion Alaris SystemCareFusion 303, Inc.
2020-03-11Z-1360-2020Class ICareFusion Alaris Pump ModuleCareFusion 303, Inc.
2020-03-11Z-1361-2020Class ICareFusion Alaris Syringe ModuleCareFusion 303, Inc.
2020-03-11Z-1362-2020Class ICareFusion Alaris PCA ModuleCareFusion 303, Inc.
2020-03-11Z-1408-2020Class IIMcGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC…Medtronic, PLC
2020-03-11Z-1409-2020Class IIRevaclear Capillary Dialyzer 300Baxter Healthcare Corporation
2020-03-11Z-1410-2020Class IIDeRoyal Sterile Custom Kits containing Cardinal Health GownsDeroyal Industries, Inc. Lafollette
2020-03-11Z-1411-2020Class IIDeRoyal Sterile Custom Kits containing Cardinal Health GownsDeroyal Industries, Inc. Lafollette
2020-03-11Z-1412-2020Class IIDeRoyal Sterile Custom Kits containing Cardinal Health GownsDeroyal Industries, Inc. Lafollette
2020-03-11Z-1413-2020Class IIDeRoyal Sterile Custom Kits containing Cardinal Health GownsDeroyal Industries, Inc. Lafollette
2020-03-11Z-1414-2020Class IIDeRoyal Sterile Custom Kits containing Cardinal Health GownsDeroyal Industries, Inc. Lafollette
2020-03-11Z-1415-2020Class IIDeRoyal Sterile Custom Kits containing Cardinal Health GownsDeroyal Industries, Inc. Lafollette
2020-03-11Z-1416-2020Class IIDeRoyal Sterile Custom Kits containing Cardinal Health GownsDeroyal Industries, Inc. Lafollette
2020-03-11Z-1417-2020Class IIDeRoyal Sterile Custom Kits containing Cardinal Health GownsDeroyal Industries, Inc. Lafollette
2020-03-11Z-1418-2020Class IIDeRoyal Sterile Custom Kits containing Cardinal Health GownsDeroyal Industries, Inc. Lafollette
2020-03-11Z-1419-2020Class IIDeRoyal Sterile Custom Kits containing Cardinal Health GownsDeroyal Industries, Inc. Lafollette
2020-03-11Z-1420-2020Class IIAIA-360 Automated Immunoassay AnalyzerTosoh Bioscience Inc
2020-03-11Z-1421-2020Class IIAtellica CH Reaction Ring SegmentSiemens Healthcare Diagnostics, Inc.
2020-03-11Z-1422-2020Class IIEnzymatic Creatinine ReagentBeckman Coulter Inc
2020-03-11Z-1423-2020Class IITriglycerides ReagentBeckman Coulter Inc
2020-03-11Z-1424-2020Class IIUric Acid ReagentBeckman Coulter Inc
2020-03-11Z-1425-2020Class IIDirect Bilirubin ReagentsBeckman Coulter Inc
2020-03-11Z-1426-2020Class IITotal Bilirubin ReagentBeckman Coulter Inc
2020-03-11Z-1429-2020Class IISeca 402/403 Baby Scale CartSeca
2020-03-11Z-1430-2020Class IIRemisol Advance running on hardware with Windows XPNormand-Info S.A.S.U.
2020-03-11Z-1431-2020Class IIBard Biopsy EnCor ProbeBard Peripheral Vascular Inc
2020-03-11Z-1432-2020Class IIBard Biopsy EnCor ProbeBard Peripheral Vascular Inc
2020-03-11Z-1433-2020Class IIBard Biopsy EnCor ProbeBard Peripheral Vascular Inc
2020-03-11Z-1434-2020Class IIBard Biopsy EnCor ProbeBard Peripheral Vascular Inc
2020-03-11Z-1435-2020Class IIAtellica IM Humidity PackSiemens Healthcare Diagnostics, Inc.
2020-03-11Z-1436-2020Class IIAtellica IM Humidity PackSiemens Healthcare Diagnostics, Inc.
2020-03-11Z-1437-2020Class IILKT200 Perfusion CircuitOrgan Recovery Systems, Inc.
2020-03-11Z-1438-2020Class IIPTS Detect CotininePolymer Technology Systems, Inc.
2020-03-11Z-1439-2020Class IIbellavista 1000 ventilatorVyaire Medical
2020-03-11Z-1440-2020Class IIMonitor for the Functional Imaging System for Magnetic Resonance…Invivo Corporation
2020-03-11Z-1441-2020Class IIISoundWave Professional Suite Software 3Advanced Bionics, LLC
2020-03-11Z-1443-2020Class IIRespVent Closed Suction System T-Piece Tracheostomy AdultRESPIRATORY THERAPEUTICS GROUP LLC
2020-03-11Z-1444-2020Class IIElecsys CA 19-9Roche Diagnostics Operations, Inc.
2020-03-11Z-1445-2020Class IIStryker Connected OR CartStryker Corporation
2020-03-11Z-1446-2020Class IICovidien Force TriVerse Electrosurgical DevicesCovidien Llc
2020-03-11Z-1447-2020Class IIKits containing Covidien Force TriVerse Electrosurgical DevicesCovidien Llc
2020-03-11Z-1448-2020Class IIIFilmArray NGDS Warrior PanelBiofire Defense
2020-03-04Z-1342-2020Class IIAmbulance Parameter ExtensionPhilips North America, LLC
2020-03-04Z-1343-2020Class IISelenia Dimensions Mammography SystemHologic, Inc.
2020-03-04Z-1345-2020Class IIPhilips DigiTrak XT Holter Recorder Software version number BPhilips North America, LLC
2020-03-04Z-1346-2020Class IICOHERENCE OncologistSiemens Medical Solutions USA, Inc
2020-03-04Z-1347-2020Class IITHP Hip Plating SystemZimmer Biomet, Inc.
2020-03-04Z-1348-2020Class IIITLC-2000 Therapeutic Medical Laser System Power PackTheralase Inc.
2020-03-04Z-1349-2020Class IIRX Daytona PlusRandox Laboratories, Limited
2020-03-04Z-1350-2020Class IIUlrich medical neon3 OCT spinal stabilizationulrich medical USA Inc
2020-03-04Z-1351-2020Class IIEllipseSt Jude Medical, Cardiac Rhythm Management Division
2020-03-04Z-1352-2020Class IIProtective Cover Vivo 55/65Breas Medical, Inc.
2020-03-04Z-1353-2020Class IIITLC-2000 Therapeutic Medical Laser SystemTheralase Inc.
2020-03-04Z-1354-2020Class IIITLC-2000 Therapeutic Medical Laser SystemTheralase Inc.
2020-03-04Z-1355-2020Class IIZenith Alpha Spiral-Z Endovascular LegCook Inc.
2020-03-04Z-1356-2020Class IIZimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and…Zimmer Surgical Inc
2020-03-04Z-1357-2020Class IIMedline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31…Medline Industries Inc
2020-03-04Z-1358-2020Class IIMedline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30…Medline Industries Inc
2020-03-04Z-1363-2020Class IIADVIA Chemistry LipaseSiemens Healthcare Diagnostics, Inc.
2020-03-04Z-1364-2020Class IITruliant Splined Stem ExtensionExactech, Inc.
2020-03-04Z-1365-2020Class IINUCLISENS¿ Lysis BufferBIOMERIEUX - Grenoble
2020-03-04Z-1366-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 3Biomet 3i, LLC
2020-03-04Z-1367-2020Class IICERTAIN¿ BELLATEK ENCODE HEALING ABUTMENT 3Biomet 3i, LLC
2020-03-04Z-1368-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 3Biomet 3i, LLC
2020-03-04Z-1369-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 3Biomet 3i, LLC
2020-03-04Z-1370-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 3Biomet 3i, LLC
2020-03-04Z-1371-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 3Biomet 3i, LLC
2020-03-04Z-1372-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 4Biomet 3i, LLC
2020-03-04Z-1373-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 4Biomet 3i, LLC
2020-03-04Z-1374-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 4Biomet 3i, LLC
2020-03-04Z-1375-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 4Biomet 3i, LLC
2020-03-04Z-1376-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 4Biomet 3i, LLC
2020-03-04Z-1377-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 4Biomet 3i, LLC
2020-03-04Z-1378-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 4Biomet 3i, LLC
2020-03-04Z-1379-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 4Biomet 3i, LLC

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