Medical devices, 2024: every recall, from FDA

Medical device recall Aligned Medical Septo Pack Due to convenience kits containing a kit component that is under a recall action for improper use. Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Missouri, Ohio, Virginia and Wyoming named

Medical device recall Aligned Medical T and A Pack Due to convenience kits containing a kit component that is under a recall action for improper use. Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Missouri, Ohio, Virginia and Wyoming named

Medical device recall Aligned Medical Tonsil Pack Due to convenience kits containing a kit component that is under a recall action for improper use. Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Missouri, Ohio, Virginia and Wyoming named

Medical device recall MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the… Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNationwide

Medical device recall MEDLINE Automatic Digital Blood Pressure Monitor It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the… Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNationwide

Medical device recall Patient Information Center iX During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNationwide

Medical device recall The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the… Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust. Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 16, 2024ClassClass IIStatusCompletedWhereNationwide, and Florida named

Medical device recall 3M Tegaderm CHG, Chlorhexidine Gluconate I.V Contamination with foreign substance matter Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNo state named

Medical device recall GE Healthcare Centricity Universal Viewer Zero Footprint Client GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) version v6.0 SP11.x where the latest report is not shown… Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNo state named

Medical device recall Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system. Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box. Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNationwide

Medical device recall Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system. Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box. Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNationwide

Medical device recall NxTAG Respiratory Pathogen Panel Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results,… Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Illinois, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin named

Medical device recall NxTAG Respiratory Pathogen Panel +SARS-CoV-2 Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results,… Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Illinois, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin named

Medical device recall MAKO Integrated Cutting System (MICS) HANDPIECE Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces. Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNationwide

Medical device recall Check-Flo Performer Introducer Set, Reference Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of… Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNo state named

Medical device recall StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with… Due to two software anomalies that can occur within a spine procedure. Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named

Medical device recall Monarch Platform (Endoscopy) Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead… Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named

Medical device recall Monarch Platform (Urology) Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead… Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named

Medical device recall Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo… CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable Endo Pocket. Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNationwide, and California named

Medical device recall MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model… There is a potential for pinholes in the applicator pouch film which creates a sterility concern. Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named

Medical device recall Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of… Software defect, when an image has non-square pixel spacing, the reference/localizer line is incorrectly placed on the scout image in the XERO Viewet, may… Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNationwide

Medical device recall MiniMed 630G Insulin Pump Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump… FDA Class I, its most serious class Class IFDA’s classOct 9, 2024in FDA’s Enforcement Report53 statesnamed in where it went PublishedOct 9, 2024ClassClass IStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming

Medical device recall MiniMed 620G Insulin Pump Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump… FDA Class I, its most serious class Class IFDA’s classOct 9, 2024in FDA’s Enforcement Report53 statesnamed in where it went PublishedOct 9, 2024ClassClass IStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming

Medical device recall MiniMed Insulin Pump Device Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump… FDA Class I, its most serious class Class IFDA’s classOct 9, 2024in FDA’s Enforcement Report53 statesnamed in where it went PublishedOct 9, 2024ClassClass IStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming

Medical device recall Neo-Tee T-Piece Resuscitator Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step. FDA Class I, its most serious class Class IFDA’s classOct 9, 2024in FDA’s Enforcement Report5 statesnamed in where it went PublishedOct 9, 2024ClassClass IStatusOngoingWhereFlorida, Indiana, Michigan, Pennsylvania and South Carolina

Medical device recall Miami J Select Collar Pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar panel can occasionally exhibit poor adhesion, which may lead… Class IIFDA’s classOct 9, 2024in FDA’s Enforcement Report39 statesnamed in where it went PublishedOct 9, 2024ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia and Washington

Medical device recall IntelliVue G7m Anesthesia Gas Module, Product Number 866173 The 866173 lntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an interruption of the gas measurement. Class IIFDA’s classOct 9, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2024ClassClass IIStatusOngoingWhereNationwide

Medical device recall BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner The bulk product used in the recalling firm’s repackaged finished product was recalled due to bacterial contamination. Class IIFDA’s classOct 9, 2024in FDA’s Enforcement Report10 statesnamed in where it went PublishedOct 9, 2024ClassClass IIStatusOngoingWhereArizona, Idaho, Maryland, Nevada, New York, Pennsylvania, South Carolina, Tennessee, Texas and Wisconsin

Medical device recall BD FACSDuet Premium Sample Preparation System Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube assay: Specimen volume dispensed into tube1 at least 3% higher… Class IIFDA’s classOct 9, 2024in FDA’s Enforcement Report13 statesnamed in where it went PublishedOct 9, 2024ClassClass IIStatusOngoingWhereAlaska, California, Idaho, Massachusetts, Maryland, Michigan, Minnesota, New Jersey, Tennessee, Texas, Utah, Virginia and Wisconsin

Medical device recall Tablo Console Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level, specified as 0.35 mL/min blood leak rate, which… Class IIFDA’s classOct 9, 2024in FDA’s Enforcement Report46 statesnamed in where it went PublishedOct 9, 2024ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming

Medical device recall Percussionaire, Inc. Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy. FDA Class I, its most serious class Class IFDA’s classOct 9, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2024ClassClass IStatusOngoingWhereNationwide

Medical device recall Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip The reason for this recall is Healgen Scientific Ltd. Class IIFDA’s classOct 9, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 9, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Georgia and Texas named

Medical device recall ADVIA Centaur aTPO Assay, Material Number 10630886 Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM… Class IIFDA’s classOct 9, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2024ClassClass IIStatusOngoingWhereNationwide

Medical device recall Atellica IM aTPO Assay, Material Number 10995466 Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM… Class IIFDA’s classOct 9, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2024ClassClass IIStatusOngoingWhereNationwide

Medical device recall DVOT SARS-CoV-2 ANTIGEN TEST KIT The “DVOT brand” rapid test kits have not obtained the necessary authorization to be sold in the United States. Class IIFDA’s classOct 9, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2024ClassClass IIStatusOngoingWhereNo state named

Medical device recall DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit The “DVOT brand” rapid test kits have not obtained the necessary authorization to be sold in the United States. Class IIFDA’s classOct 9, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2024ClassClass IIStatusOngoingWhereNo state named

Medical device recall DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit The “DVOT brand” rapid test kits have not obtained the necessary authorization to be sold in the United States. Class IIFDA’s classOct 9, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2024ClassClass IIStatusOngoingWhereNo state named

Medical device recall Stryker Tornier Perform Humeral System, Reversed Insert, 45% Devices from one lot of Perform” Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from… Class IIFDA’s classOct 9, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2024ClassClass IIStatusOngoingWhereNationwide

Medical device recall BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or… Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity Class IIFDA’s classOct 9, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2024ClassClass IIStatusOngoingWhereNationwide

Medical device recall Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or… Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity Class IIFDA’s classOct 9, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2024ClassClass IIStatusOngoingWhereNationwide

Medical device recall DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system If the DIVA touch display generates touch inputs without user interaction, due to possibility of the erroneous acknowledgement of a patient alarm, there is a… Class IIFDA’s classOct 9, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 9, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Illinois, Maine, North Carolina, New Jersey, New Mexico, New York, Ohio, Virginia and Washington named

Medical device recall DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere Material with a quality issue was used in contact lens production, so contact lenses may not meet quality and/or performance standards for the entirety of… Class IIFDA’s classOct 9, 2024in FDA’s Enforcement Report51 statesnamed in where it went PublishedOct 9, 2024ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming

Medical device recall GE Giraffe Warmer GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNo state named

Medical device recall GE Panda iRES Warmer GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNo state named

Medical device recall paraPAC plus 310 ventilator kit with internal PEEP and CPAP Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310… FDA Class I, its most serious class Class IFDA’s classOct 2, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 2, 2024ClassClass IStatusOngoingWhereNo state named

Medical device recall paraPAC 300 ventilator kit without internal PEEP and CPAP Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310… FDA Class I, its most serious class Class IFDA’s classOct 2, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 2, 2024ClassClass IStatusOngoingWhereNo state named

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