BEUDAMED
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    LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s office, and clinic setting by personnel who are authorized by a physician/medical director. It is intended for use on a crash cart as well as for portable emergency response throughout a hospital.

    FDA Recall
    Terminated ·Physio-Control, Inc.·Product code MKJ·December 4, 2017

    Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aortic Balloon Pump; CS300 Intra-Aortic Balloon Pump; Manufactured by Datascope Corp., 1300 MacArthur Blvd., Mahwah, NJ 07430 The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloon. It provides temporary support to the left ventricle via the principle of counterpulsion. The IABP is placed in the descending aorta, via the principe of counterpulsation. The IABP is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the IABP is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle. The CS300 has the additional capability to automatically calibrate a fiber-optic pressure sensor placed in the tip of the intra-aortic balloon. The IABP will recalibrate every 2 hours or sooner should the patient or environmental conditions change. The target populations are adult and pediatric. The IABP is intended for use in the health care facility setting.

    FDA Recall
    Terminated ·Maquet Datascope Corp Cardiac Assist Division·Product code FMZ·March 16, 2011

    LeadCare Blood Lead Testing System Kits Catalog Number: 70-2233

    FDA Recall
    Terminated ·Esa Biosciences, Inc.·Product code DOF·May 19, 2005

    ESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-7142

    FDA Recall
    Terminated ·Esa Biosciences, Inc.·Product code DOF·September 20, 2007

    LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a calibration button. The LeadCare II Lead Controls packaged in the kit lots listed in #2 below are the subject of this recall (Field Correction) action.

    FDA Recall
    Terminated ·Magellan Diagnostics, Inc.·Product code DOF·January 20, 2016

    LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098

    FDA Recall
    Terminated ·Magellan Diagnostics, Inc.·Product code DOF·May 7, 2021

    ESA LeadCare II Blood Test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-6762

    FDA Recall
    Terminated ·Esa Biosciences, Inc.·Product code DOF·September 20, 2007

    Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.

    FDA Recall
    Terminated ·Magellan Diagnostics, Inc.·Product code DOF·May 23, 2017

    Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010

    FDA Recall
    Terminated ·Magellan Diagnostics, Inc.·Product code DOF·November 29, 2014

    Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.

    FDA Recall
    Terminated ·Magellan Diagnostics, Inc.·Product code DOF·May 23, 2017

    Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010

    FDA Recall
    Terminated ·Magellan Diagnostics, Inc.·Product code DOF·November 29, 2014

    Magellan LeadCare II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II Blood Lead Test Kit is for in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and treatment reagent of the test kit are specific for lead only. Contents of the LeadCare II Blood Lead Test Kit must only be used with a LeadCare II Analyzer.

    FDA Recall
    Terminated ·Magellan Diagnostics, Inc.·Product code DOF·August 8, 2018

    LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.

    FDA Recall
    Terminated ·Magellan Diagnostics, Inc.·Product code DOF·January 9, 2018

    LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only.

    FDA Recall
    Terminated ·Magellan Diagnostics, Inc.·Product code DOF·January 9, 2018

    LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004

    FDA Recall
    Terminated ·Magellan Diagnostics, Inc.·Product code DOF·May 7, 2021

    LeadCare II Blood Lead Test Kit Catalog Number 70-6762

    FDA Recall
    Terminated ·Magellan Diagnostics, Inc.·Product code DOF·May 7, 2021

    8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202

    FDA Enforcement
    Class II ·Terminated·Trilliant Surgical, LLC·April 8, 2020

    Dow Corning Silastic brand Medical Adhesive Silicone, Type A, non-sterile, 57 gram tube; material numbers 3242901 (100 tubes) and 3242897 (6 tubes).

    FDA Recall
    Terminated ·Dow Corning Corp.·September 5, 2003

    Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)

    FDA Enforcement
    Class II ·Terminated·MEDLINE INDUSTRIES, LP - Northfield·April 20, 2022

    Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)

    FDA Recall
    Terminated ·MEDLINE INDUSTRIES, LP Northfield·Product code JIN·March 8, 2022