BEUDAMED
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    Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and large on the Maxi Sky 2 Ceiling Lift; Model 700-19425. Intended to be used for general transfers in hospitals.

    FDA Recall
    Terminated ·Arjo, Inc. dba ArjoHuntleigh·Product code FSA·January 21, 2013

    Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, Product Code: 90003, in vitro diagnostic.

    FDA Recall
    Terminated ·Binax, Inc. dba IMPD·Product code GTZ·April 6, 2009

    BinaxNOW Influenza A&B 10 Test KIT Part Number: 416-110 contains NP Swabs with '8995' labeled on the swab wrapper

    FDA Recall
    Terminated ·Binax, Inc. dba IMPD·Product code GNX·March 28, 2007

    BinaxNOW Influenza A&B 22 Test Kit Part Number: 416-022, contains NP Swabs with '8995' labeled on the swab wrapper

    FDA Recall
    Terminated ·Binax, Inc. dba IMPD·Product code GNX·March 28, 2007

    Entroy Pool Lift; a patient lift used in conjunction with a chair or stretcher to lift them in/out of a swimming/therapy pool; Arjo Hospital Equipment AB, Eslov, Sweden; Models GAB1000-01-xx, GAB1000-11-xx and GAC100x Entroy is a pool lift that docks to either a chair or a stretcher and aids disabled people getting in and out of a pool. This equipment is intended for disabled persons who need to transfer in and out of a therapy and swimming pool under supervision of skilled and trained personnel in accordance with the Entroy Operating and Product Care Instructions. All other use must be avoided. Active/semi-active persons can and should use the Entroy chair (with or without chassis) while bedridden persons without trunk stability can and should be transferred with the Entroy stretcher with chassis.

    FDA Recall
    Terminated ·Arjo, Inc. dba ArjoHuntleigh·Product code FSA·August 4, 2011

    Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5022-21US and KKB5042-21US. The Encore is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position to another, and to elevate a patient for toileting, repositioning, changing of incontinence pads or wound dressings, standing practice etc. it is not intended for long periods of suspension or transportation.

    FDA Recall
    Terminated ·Arjo, Inc. dba ArjoHuntleigh·Product code FSA·June 29, 2012

    Genicon 5mm Pyramidal Trocar, Sterile, Genion 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792, Rx Only. Catalog Numbers: 100-005-001 & 100-005-002. Used for incisions made for positioning the laparoscopic cannulas or ports.

    FDA Recall
    Terminated ·Genico, Inc., dba Genicon·Product code GEA·September 25, 2008

    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 Recall
    Terminated ·INO Therapeutics (dba Ikaria)·Product code MRN·March 27, 2014

    Maxi Sky 1000/BHM Medical V10 Bariatric Ceiling Lift System; a patient transfer lift; ArjoHuntleigh, Addison, IL 60101; Model numbers LF20010, LF20011, LF20013, LF20014, LF20015, LF21015, LF21019, 9120001, 9120004, 9120005, 9120008, 9120009 and 9121009 The Maxi Sky 1000 is designed for lifting patients in a homecare setting, at nursing homes and other assisted living centers, as well as in institutional or hospital settings. Patient transferring is performed under the supervision of an appropriately trained caregiver staff, in accordance with the instructions for use. All other uses must be avoided.

    FDA Recall
    Terminated ·Arjo, Inc. dba ArjoHuntleigh·Product code FSA·March 21, 2011

    Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Products N.V., Heikant 5, B-3930 Hamont-Achel, Belgium; Models HEP0001-US and HEP1001-US. The Sara Plus is a standing and raising aid for short transfers e.g. raising from bed and transfer to wheelchair, or from wheelchair to toilet. Sara Plus is also suitable for walking training when the footboard and kneepad are removed.

    FDA Recall
    Terminated ·Arjo, Inc. dba ArjoHuntleigh·Product code FSA·June 29, 2012

    INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal Intensive Care Units (NICU) and to transport of neonates.

    FDA Recall
    Terminated ·INO Therapeutics (dba Ikaria)·Product code MRN·October 17, 2014

    0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe.

    FDA Recall
    Terminated ·MRP, LLC dba AMUSA·Product code NGT·April 27, 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 Recall
    Terminated ·INO Therapeutics (dba Ikaria)·Product code MRN·November 21, 2016

    Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov, Sweden; Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800 General medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care and oncology. The bed is appropriate for high dependency patients who pose a movement and handling risk and/or whose clinical condition requires that they are positioned with the minimal physical handling.

    FDA Recall
    Terminated ·Arjo, Inc. dba ArjoHuntleigh·Product code FNL·November 16, 2012

    Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB, Eslov, Sweden; Model 512003; a non-invasive prophylaxis system for reducing the incidence of deep vein thrombosis.

    FDA Recall
    Terminated ·Arjo, Inc. dba ArjoHuntleigh·Product code JOW·December 10, 2012

    0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.

    FDA Recall
    Terminated ·MRP, LLC dba AMUSA·Product code NGT·July 2, 2015

    Genicon, RX Only, Sterile EO. Genicon 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792. EC REP Genicon Europe, Ltd. 44 Airedale Avenue, Chiswick London U.K. W4 2NW. Catalog Number 700-010-005, 10MM (Foreign Distribution Only). A suction irrigation device. This device is used in conjunction with an insufflator during laparoscopic surgery to provide suction and irrigation to the surgical site. The suction irrigation product contains a trumpet valve handpiece that fits into either the left or right hand. The double sealing valve system provides operation of the suction and irrigation functions while preventing fluid leakage.

    FDA Recall
    Terminated ·Genico, Inc., dba Genicon·Product code GCY·May 8, 2008

    Genicon, RX Only, Sterile EO. Genicon 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792. EC REP Genicon Europe, Ltd. 44 Airedale Avenue, Chiswick London U.K. W4 2NW. Catalog Number 700-005-010, 5MM. A suction irrigation device. This device is used in conjunction with an insufflator during laparoscopic surgery to provide suction and irrigation to the surgical site. The suction irrigation product contains a trumpet valve handpiece that fits into either the left or right hand. The double sealing valve system provides operation of the suction and irrigation functions while preventing fluid leakage.

    FDA Recall
    Terminated ·Genico, Inc., dba Genicon·Product code GCY·May 8, 2008

    The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and bathing of residents in care environments such as senior/assisted living, group home, special care, nursing homes, hospitals and home care. The Concerto Basic Shower Trolley is intended for indoor use.

    FDA Recall
    Terminated ·Arjo, Inc. dba ArjoHuntleigh·Product code FSA·December 21, 2015

    Rolko Adjustable (retractable) Strap and Handle, type TGN-R100GR; a component of a Lifting Pole, an accessory to long term care hospital beds such as ArjoHuntleigh's Minuet 2 Community bed and Enterprise series hospital beds; Distributed by ArjoHuntleigh, a Branch of Arjo Limited Med AB, Wednesbury, United Kingdom Lifting poles are accessories intended to assist patients in positioning themselves on a hospital bed and the lifting pole is used in conjunction with a strap and handle. The strap and handle hangs from the lifting pole and the patient grasps the handle to pull upon the strap when repositioning themselves

    FDA Recall
    Terminated ·Arjo, Inc. dba ArjoHuntleigh·Product code FNK·February 24, 2011