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    West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117. 510(k) No. K031953 The Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Diagnostics West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningoencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection.

    FDA Enforcement
    Class III ·Terminated·Focus Diagnostics Inc·November 7, 2012

    Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100 with software versions 3.0.x.x and higher, with Normative Database, manufactured by Optovue, Fremont, CA The RTVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Recall
    Terminated ·Optovue Inc.·Product code OBO·January 8, 2010

    West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117. 510(k) No. K031953 The Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Diagnostics West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningoencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection.

    FDA Recall
    Terminated ·Focus Diagnostics Inc·Product code NOP·October 3, 2012

    Drop Hooks for Xact (tm) Lo-Pro with Removeable Drop Seat, Xact Integrated, and Xact Individual with Integrated Drop Seat wheelchairs, model/item numbers 05D, 1D, and 15D. Packaged as set of four in a poly bag.

    FDA Recall
    Terminated ·Action Products Incorporated·Product code KNO·May 14, 2002

    Xact(tm) Drop Seat Base, a plastic seat support in Xact (tm) Integrated and Xact Individual w/ Drop seat Base Wheelchair cushions.

    FDA Recall
    Terminated ·Action Products Incorporated·Product code KNO·February 2, 2004

    Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.

    FDA Recall
    Terminated ·Merits Holdings Co. dba Merits Health Products, Inc.·Product code KNO·March 2, 2020

    Maquet Getinge-BEQ-TOP 49103 ECC Pack 0 No Bladder Material: 709000058

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·June 5, 2019

    Sarns Cardioplegia Set CPLG BLD MP4 4:1 No recirculation, Item # 16010

    FDA Recall
    Terminated ·Terumo Cardiovascular Corporation·Product code DTR·June 8, 2010

    Maquet Getinge-BEQ-TOP 49103 ECC Pack 0 No Bladder Material: 709000058

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019

    Terumo Cardiovascular Procedure Kit Custom CONDUCER/MP4 8:1 NO RECIRC. DOUBLE SPIKE P/N: 71032

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTR·June 8, 2010

    AUTION HYBRID AU-4050

    FDA Enforcement
    Class II ·Terminated·Arkray Factory USA, Inc.·June 26, 2019

    eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.

    FDA Enforcement
    Class II ·Terminated·Philips Visicu·May 4, 2016

    AUTION HYBRID AU-4050

    FDA Recall
    Terminated ·Arkray Factory USA, Inc.·Product code KQO·May 3, 2019

    CS5/5+ Fastpacks, 125 mL, 20¿ Res Autotransfusion Device- Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.

    FDA Enforcement
    Class II ·Terminated·Haemonetics Corporation·February 5, 2020

    High Speed Cell Saver¿5/5+ Bowl Set Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.

    FDA Enforcement
    Class II ·Terminated·Haemonetics Corporation·February 5, 2020

    JAPAN CELL SAVER ELITE SET - 125ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient.

    FDA Enforcement
    Class II ·Terminated·Haemonetics Corporation·February 5, 2020

    eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.

    FDA Recall
    Terminated ·Philips Visicu·Product code DRG·March 10, 2016

    Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.

    FDA Enforcement
    Class II ·Terminated·INO Therapeutics (dba Ikaria)·March 11, 2015

    Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalation). The INOmax DSIR uses a dual-channel design to ensure the safe delivery of INOMAX. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and 02 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOMAX delivery independent of monitoring but also allows the monitoring system to shutdown INOMAX delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm. The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.

    FDA Enforcement
    Class II ·Terminated·INO Therapeutics (dba Ikaria)·February 1, 2017

    INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.

    FDA Enforcement
    Class II ·Terminated·INO Therapeutics (dba Ikaria)·May 14, 2014