BEUDAMED
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    Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303

    FDA Recall
    Terminated ·Diagnostic Products Corp·Product code DHX·May 26, 2005

    CE 2 ML PATIENT CONTROL MODULESINGLE PACK 6/CARTON

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEA·February 19, 2010

    CE 2 ML PATIENT CONTROL MODULESINGLE PACK 6/CARTON

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code MEA·November 3, 2008

    CE 2 ML PATIENT CONTROL MODULESINGLE PACK 6/CARTON

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code MEA·November 13, 2008

    CE 2 ML PATIENT CONTROL MODULESINGLE PACK 6/CARTON

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEA·December 30, 2010

    CE 2 ML PATIENT CONTROL MODULESINGLE PACK 6/CARTON

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEA·November 12, 2010

    DEX II BE 1X18 CE2 4/0 N/S

    FDA Adverse Event
    Malfunction ·MANATI - USS·Product code GAN·December 28, 2001

    DEX II BE 1X18 CE2 4/0 N/S

    FDA Adverse Event
    Malfunction ·MANATI - USS·Product code GAM·December 12, 2001

    DEX S BE 1X18 CE2 4/0 N/S

    FDA Adverse Event
    Malfunction ·MANATI - USS·Product code GAN·April 26, 2002

    VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·July 18, 2018

    VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·July 18, 2018

    VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·July 18, 2018

    Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·July 18, 2018

    CEA ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.

    FDA Recall
    Terminated ·BioCheck Inc·Product code DHX·December 22, 2010

    The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.

    FDA Enforcement
    Class II ·Ongoing·Ithera Medical Gmbh·February 19, 2025

    Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 Catalog 1125, Burn Navigator¿ H2 Transport Package Burn Navigator User Manual Manual-1120 Burn Navigator User's Manual, Rev. F Battery: Panasonic Model CF-H2 Part Number CMP-1523

    FDA Enforcement
    Class II ·Terminated·Arcos, Inc·August 28, 2019

    Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads. Water is poured into a reservoir in the device's housing. The steam cycle is followed by a drying cycle.

    FDA Enforcement
    Class II ·Terminated·Ceg Enterprises Llc·June 29, 2016

    CE 2 ML PATIENT CONTROL MODULE SINGLE PACK 6/CARTON

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code MEA·October 21, 2008

    CE 2 ML PATIENT CONTROL MODULE SINGLE PACK 6/CARTON

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code MEA·October 31, 2008

    CE 2 ML PATIENT CONTROL MODULE SINGLE PACK 6/CARTON

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code MEA·November 24, 2008