BEUDAMED
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    AxSYM CA 125 Master Calibrators, list 3B41-30; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code LTK--·November 25, 2003

    IMx CA 125 Mode 1 Calibrator, list 7A89-40; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code LTK--·November 25, 2003

    CA 125 Controls, list 9C22-10; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code LTK--·November 25, 2003

    AxSYM CA 125 Reagent Pack; list 03B41; 100 test pack; an in vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories·Product code LTK·April 23, 2007

    VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System for the quantitative measurement of OC 125 defined antigen in human serum and plasma (EDTA or heparin).

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code LTK·October 9, 2013

    ADVIA Centaur CA 125 II Assay packaged in 100 and 500 test kits as follows: Product code: 09427226 (128532) 100 test kit Product code: 01678114 (128533) 500 Test kit

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code LTK·December 14, 2010

    CA 125 Calibrators, list 9C22-01; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code LTK--·November 25, 2003

    CA125 ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.

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

    AxSYM CA 125 Reagent Pack, list 3B41-22 and IMx CA 125 Reagent Pack, list 7A89-22; 100 test kits; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code LTK--·November 25, 2003

    IMMULITE /IMMULITE 1000 OM-MA (CA125)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LTK·January 2, 2018

    IMMULITE 2000/IMMULITE 2000 XPi OM-MA (CA125)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LTK·January 2, 2018

    ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code LTK·February 21, 2018

    CA15-3 ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.

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

    Left Atrial Catheter Set

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 21, 2018

    Titanium Greenfield Vena Cava Filter with 12 Fr./4,0 mm Introducer System. Catalog no. M001503010. Sterile EO. Single Use Only. Manufacturer: Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd., Cork, Ireland. Distributed in USA by: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA USA 01760. The devices are permanently implanted devices designed to protect against pulmonary embolism while maintaining patency of the inferior vena cava. It is inserted through the internal jugular or femoral vein using a percutaneous puncture or surgical cutdown. The Titanium Greeenfield Vena Cava Filter comes preloaded in a jugular or a femoral introducer catheter.

    FDA Recall
    Terminated ·Boston Scientific Scimed·Product code DTK·August 5, 2005

    Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP Catheter Sheath Introducer and Angiographic Vessel Dilator)***Cordis***a Johnson and Johnson Company***ENDOVASCULAR*** Label No. SB 10247519.2/***LB466F220AO.5***omoraoro/2012.050794***Do not resterilize***. Product Usage: The OPTEASE Vena Cava Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in several situations: Pulmonary thromboembolism when anticoagulants are contraindicated; Failure of anticoagulant therapy for thromboembolic disease; Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced and Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.

    FDA Recall
    Terminated ·Cordis Corporation·Product code DTK·March 29, 2013

    Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-TULIP Product Usage: The Gunther Tulip Filter is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations:(1) Pulmonary thromboembolism when anticoagulant therapy is contraindicated; (2) Failure of anticoagulant therapy in thromboembolic diseases; (3) Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and (4) Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Filter implant may be retrieved if clinically indicated. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

    FDA Recall
    Terminated ·Cook Medical Incorporated·Product code DTK·February 25, 2019

    Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code LBK·January 7, 2013

    Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog Number GTCFS-65-1-JUG-CELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: Pulmonary thromboembolism when anticoagulant therapy is contraindicated; Failure of anticoagulant therapy in thromboembolic diseases; Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Filter implant may be retrieved if clinically indicated. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

    FDA Recall
    Terminated ·Cook Medical Incorporated·Product code DTK·February 25, 2019

    G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the prevention of recurrent pulmonary embolism. Catalog Number RF-320J

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code DTK·December 20, 2006