BEUDAMED
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    Velara Generator with an old Firmware version used with the Philips Integris BH5000

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code IZI·December 9, 2016

    Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716, 1076717, DU1053617, U1053617. Old Material No. 850008, 989805628251, 989805612101, 989805613391, 989805613661, 989805611761, 989805627411, 989805627431, 989805627441, 989805616411, 989805636631.

    FDA Recall
    Terminated ·Respironics California Inc·Product code MNT·April 24, 2017

    Velara Generator with an old Firmware version used with Philips Allura Xper Systems (Allura 15 & 12 (monoplane), Allura FD10C, Allura FD10F, Allura FD 10 F/C, Allura FD20, Allura XPER FD10/10, Allura XPER FD20 Biplane)

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code IZI·December 9, 2016

    Material DT6110, PORT ACCESS TRAY WITH HUBER NEEDLE, LINWOOD, Distributed By: Midland Medical Supply Company 4850 Old Cheney Road Lincoln, Nebraska 68516 (402) 423-8877 (800) 742-2895, PORT ACCESS TRAY WITH HUBER NEEDLE, REORDER DT6110, STERILE..., LATEX FREE FACILITATES LINE INSERTION

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code MCY·March 31, 2011

    LySonix 2000 Ultrasonic Surgical Systems, MODEL NO. LY-2000. --- Old labeling: MANUFACTURED BY: MISONIX, INC. EXCLUSIVELY FOR SALE BY MENTOR CORPORATION UNDER EXCLUSIVE LICENSE FROM SONIQUE SURGICAL, INC. MISONIX, INC. 1938 NEW HIGHWAY, FARMINGDALE, NY 11735. Device was manufactured from September 1996 to present.

    FDA Recall
    Terminated ·Misonix, Inc·Product code LFL·August 13, 2003

    SKINTACT Electrodes for Defibrillation, 10X REF DF20, Rx only, Manufactured by Leonhard Lang GmbH, Archenweg 56, 6020 Innsbruck, Austria. The device is non-sterile and single use. For use on adults and children over eight years old for external defibrillation, pacing, monitoring, and cardioversion.

    FDA Recall
    Terminated ·Leonhard Lang Gmbh Archenweg 56 Innsbruck Austria·Product code MKJ·July 10, 2009

    S&W Electrodes for Defibrillation, 10 Defibrillation Electrodes, Reorder #90101, S & W Healthcare Corp, 1525 Flight Path Drive Brooksville, Florida 34604 The device is non-sterile and single use. For use on adults and children over eight years old for external defibrillation, pacing, monitoring, and cardioversion.

    FDA Recall
    Terminated ·Leonhard Lang Gmbh Archenweg 56 Innsbruck Austria·Product code MKJ·July 10, 2009

    The Routine Service Kit #082395-00 or Part #030500-00 for HLD SYSTEM and it is labeled in part: "HLD SYSTEMS ***FOR SALES.SERVICE.SUPPLIES CALL***Cenorin*** Kent, WA 98032***P:800.426.1042***F: 253.395.2650***www.cenorin.com". Service Kit P/N: 082395-00 Series 500 Water Level Switch Upgrade Kit: The purpose of this service kit was to provide replacement parts for customers who had HLD Systems that were manufactured prior to 3/22/07.These systems were manufactured with old, old switches that have been obsolete and discontinued. Part P/N: 030500-00 Switch, Liquid Level: This part was sold by itself to a foreign consignee in Japan for inventory purposes only for regularly scheduled maintenance of a device or replacement of parts at the end of their normal life expectancy.

    FDA Recall
    Terminated ·Cenorin·Product code LDS·June 7, 2010

    Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are used with disposable pads applied to potential victims of SCA with the following symptoms: 1) Unresponsiveness 2) Absence of normal breathing The HeartStart FR3 is intended for adults and children over 55 pounds (25kg) or 8 years old. Both models 861388 and 861389 are also intended for children under 55 pounds (25kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child s age or weight, do not delay treatment. Device not sterile and not implantable.

    FDA Recall
    Terminated ·Philips Electronics North America Corp.·Product code MKJ·October 10, 2018

    TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies Ltd., The Old Coach House, Farleigh Wallop, Hants, UK RG25 2HT. Indicated for 3 Lead ECG monitoring and 12 Lead ECG recording, non-invasive blood pressure (NIBP), respiration, end-tidal C02 (ETCO 2), pulse oximetry (SP02) and tympanic temperature.

    FDA Recall
    Terminated ·Remote Diagnostic Technologies Ltd. The Old Coach House, The Av. Farleigh Wallop, Basingstoke Hampshire United Kingdom·Product code MWI·March 25, 2011

    HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is indicated for use in patients greater than or equal to 2 years old with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.

    FDA Recall
    Terminated ·Transonic Systems Inc 34 Dutch Mill Rd Warren Road Business Park Ithaca NY 14850-9785·Product code DXG·March 28, 2013

    NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a trocar needle into the bone marrow of a patient and allows connection of syringe or IV administration set. The NIO-A is intended for adults above 12 years old and the NIO-P is intended for pediatric patients 3 - 12 years of age.

    FDA Recall
    Terminated ·Waismed Ltd 10, Amal St Rosh Haayin Israel·Product code FMI·August 18, 2016

    Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1

    FDA Recall
    Terminated ·American Medical Systems·Product code FTL·July 28, 2003

    i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code CHL·September 8, 2011

    ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma on the ARCHITECT iSystem.

    FDA Recall
    Terminated ·Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany·Product code JKC·December 14, 2017

    RenalPure Liquid Acid Concentrate R-006; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.

    FDA Recall
    Terminated ·Rockwell Medical Technologies, Inc·Product code KPO·December 3, 2007

    RenalPure Liquid Acid Concentrate R-235; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.

    FDA Recall
    Terminated ·Rockwell Medical Technologies, Inc·Product code KPO·December 3, 2007

    RenalPure Liquid Acid Concentrate R-259; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.

    FDA Recall
    Terminated ·Rockwell Medical Technologies, Inc·Product code KPO·December 3, 2007

    Glacial Acidic Acid (liquid component of Dri-Sate Dry Acid Concentrate DR-215); 1 quart (0.95 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.

    FDA Recall
    Terminated ·Rockwell Medical Technologies, Inc·Product code KPO·December 3, 2007

    Dri-Sate Glacial Acidic Acid (liquid component of Dri-Sate Dry Acid Concentrate DR-240); 1 quart (0.95 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.

    FDA Recall
    Terminated ·Rockwell Medical Technologies, Inc·Product code KPO·December 3, 2007