BEUDAMED
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    VITEK 2 Gram-Negative identification card (GN), IVD, REF 21341, 20 cards per carton.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LQM·April 20, 2017

    GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/CO-Ox/tBili 75 test iQM Part Number: 00027407509 150 test iQM Part Number: 00027415009 300 test iQM Part Number: 00027430009 450 test iQM Part Number: 00027445009 600 test iQM Part Number: 00027360009 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, 02Hb, COHb, MetHb, HHb) parameters

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code CEM·May 31, 2011

    GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/CO-Ox 75 test iQM Part Number: 00027407508 150 test iQM Part Number: 00027415008 300 test iQM Part Number : 00027430008 450 test iQM Part Number: 00027445008 600 test iQM Part Number: 00027360008 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, 02Hb, COHb, MetHb, HHb) parameters

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code CEM·May 31, 2011

    GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/G/L/CO-Ox/tBili : 75 test iQM Part Number:00027407511 150 test iQM Part Number: 00027415011 300 test iQM Part Number: 00027430011 450 test iQM Part Number: 00027445011 600 test iQM part Number: 00027360011 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, 02Hb, COHb, MetHb, HHb) parameters.

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code CEM·May 31, 2011

    GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/G/L/CO-Ox 75 test iQM Part Number : 00027407510 150 test iQM Part Number:00027415010 300 test iQM Part Number: 00027430010 450 test iQM Part Number: 00027445010 600 test iQM Part number: 00027360010 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, 02Hb, COHb, MetHb, HHb) parameters

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code CEM·May 31, 2011

    Lamis Tubing Set, 9'; 10/box; Part Number LAM-TUBING; distributed by Mentor Texas, LP, Irving, TX 75038.

    FDA Recall
    Terminated ·Mentor Texas, Inc·Product code FPK·April 21, 2008

    Y Tubing Set, 9'; 10/box; Part Number LAM-Y; distributed by Mentor Texas, LP, Irving, TX 75038.

    FDA Recall
    Terminated ·Mentor Texas, Inc·Product code FPK·April 21, 2008

    Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system designed to automate sample handling and processing in the clinical laboratory. The system allows consolidations of multiple clinical chemistry and immunoassay analytical instruments into a unified workstation.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories·June 10, 2020

    Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0615, Size #15, General Surgical Use, Sterile, unless package is damaged or opened., Southmedic Inc., 50 Alliance Blvd., Barrie, ON., Canada L4M 5K3 www.southmedic.com, Made in Canada.

    FDA Recall
    Terminated ·Southmedic, Inc. 50 Alliance Blvd. Barrie Canada Ontario·Product code GDX·September 3, 2010

    Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0610, Size #10, General Surgical Use, Sterile, unless package is damaged or opened., Southmedic Inc., 50 Alliance Blvd., Barrie, ON., Canada L4M 5K3 www.southmedic.com, Made in Canada.

    FDA Recall
    Terminated ·Southmedic, Inc. 50 Alliance Blvd. Barrie Canada Ontario·Product code GDX·September 3, 2010

    Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0611, Size #11, General Surgical Use, Sterile, unless package is damaged or opened., Southmedic Inc., 50 Alliance Blvd., Barrie, ON., Canada L4M 5K3 www.southmedic.com, Made in Canada.

    FDA Recall
    Terminated ·Southmedic, Inc. 50 Alliance Blvd. Barrie Canada Ontario·Product code GDX·September 3, 2010

    Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system designed to automate sample handling and processing in the clinical laboratory. The system allows consolidations of multiple clinical chemistry and immunoassay analytical instruments into a unified workstation.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code CEM·April 2, 2020

    Adult ThermoGard Dual Dispersive Electrodes (for patients >15 kg.), No Cable, Catalog Number 51-7410. Intended to be used for the dispersion and return to the electrosurgical generator.

    FDA Recall
    Terminated ·Conmed Corporation·Product code GEI·May 18, 2016

    Pediatric ThermoGard Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710. Intended to be used for the dispersion and return to the electrosurgical generator.

    FDA Recall
    Terminated ·Conmed Corporation·Product code GEI·May 18, 2016

    Adult ThermoGard Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.05m) Cable, Catalog Number 51-7310. Intended to be used for the dispersion and return to the electrosurgical generator.

    FDA Recall
    Terminated ·Conmed Corporation·Product code GEI·May 18, 2016

    Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC generators or conventional electrosurgery units with similar contact monitoring systems, 10' (3.05m) Cable, Catalog Number 7-382. Intended to be used for the dispersion and return to the electrosurgical generator.

    FDA Recall
    Terminated ·Conmed Corporation·Product code GEI·May 18, 2016

    Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC generators or conventional electrosurgery units with similar contact monitoring systems, 10' (3.05m) Cable, Catalog Number 7-383. Intended to be used for the dispersion and return to the electrosurgical generator.

    FDA Recall
    Terminated ·Conmed Corporation·Product code GEI·May 18, 2016

    Pediatric Laryngo-Tracheal Atomizer Device without syringe, LATEX FREE For Single patient Use Only Packaged Clean -Non-Sterile-, MADE IN CANADA. REF: LTAD-PL7-25, Lot 121508, packed 25 per package. REF: LTAD-PL7-100, Lot 121508, packed 100 per package. Southmedic 50 alliance Blvd., Barrie, Ontario, Canada L4M 5K3. Distributed By: Sharn Inc. Anesthesia, 1-800-325-3671 813-886-2701 email: [email protected] The device is used to deliver a fine mist numbing agent to the nose or throat for intubating a patient immediately prior to undergoing anesthesia.

    FDA Recall
    Terminated ·Sharn, Inc.·Product code CCT·March 5, 2009

    Nasal Mucosal Atomizer Device with syringe, LATEX FREE For Single Patient Use Only Packaged Clean -Non-Sterile- MADE IN CANADA. REF: LTAD-N1-25, Lot 121608, packed 25 per package. REF: LTAD-N1-100, Lot 121608, packed 100 per package. Manufactured By: Southmedic 50 alliance Blvd, Barrie, Ontario, Canada L4M 5K3. Distributed By: Sharn Inc. Anesthesia 1-800-325-3671 813-886-2701 email: [email protected] The device is used to deliver a fine mist numbing agent to the nose or throat for intubating a patient immediately prior to undergoing anesthesia.

    FDA Recall
    Terminated ·Sharn, Inc.·Product code CCT·March 5, 2009

    Nasal Mucosal Atomizer Device without syringe, LATEX FREE For Single Patient Use Only Packaged Clean -Non-Sterile- MADE IN CANADA. REF: LTAD-N3-25, Lot 121608, packed 25 per package. REF: LTAD-N3-100, Lot 121608, packed 100 per package. Manufactured By: Southmedic 50 alliance Blvd, Barrie, Ontario, Canada L4M 5K3. Distributed By: Sharn Inc. Anesthesia 1-800-325-3671 813-886-2701 email: [email protected] The device is used to deliver a fine mist numbing agent to the nose or throat for intubating a patient immediately prior to undergoing anesthesia.

    FDA Recall
    Terminated ·Sharn, Inc.·Product code CCT·March 5, 2009