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    RNeasy DSP FFPE Kit (48), REF 73604 - Product Usage: The RNeasy DSP FFPE Kit is a system intended for the purification of total RNA from formalin-fixed, paraffin embedded (FFPE) tissues. The product is intended to be used by professional users, such as technicians and physicians that are trained in molecular biological techniques. It deploys an optimized silica spin-column-based protocol, and includes enzymatic removal of residual DNA. The RNeasy DSP FFPE Kit is intended for in vitro diagnostic use.

    FDA Recall
    Terminated ·Qiagen Sciences, Inc.·Product code NTW·May 6, 2019

    QIAamp DSP Virus Kit Cat. No. 60704

    FDA Recall
    Terminated ·Qiagen, GmbH Qiagen Str. 1 Hilden Germany·Product code N/A·July 22, 2017

    EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.

    FDA Recall
    Terminated ·QIAGEN 19300 GERMANTOWN RD GERMANTOWN MD 20874 USA KOELN Germany·Product code JJH·May 28, 2018

    The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery.

    FDA Recall
    Terminated ·Alcon Grieshaber AG Winkelriedstrasse 52 Schaffhausen Switzerland·Product code HQE·April 17, 2013

    Smith & Nephew Endoscopic Disposable Blades: STONECUTTER ACR,4.0,EP-1,DSP Part #: 7205330. DYONICS Series 3000 BONECUTTER Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty.

    FDA Recall
    Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code NBH·May 7, 2009

    Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.

    FDA Recall
    Terminated ·Alcon Research LLC Aspex Facility·Product code HQL·April 17, 2020

    Hypodermic Needle, 16G X 1.5in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

    FDA Recall
    Terminated ·International Medsurg Connection, Inc.·Product code FMI·June 23, 2017

    Hypodermic Needle, 18 G X 1 in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

    FDA Recall
    Terminated ·International Medsurg Connection, Inc.·Product code FMI·June 23, 2017

    8 FR 40CC Rediguard IAB, IAB-S840C, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.

    FDA Recall
    Terminated ·Arrow International, Inc.·Product code DSP·February 2, 2009

    8 Fr 30cc FIBEROPTIX IAB, IAB-05830-LWS, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.

    FDA Recall
    Terminated ·Arrow International, Inc.·Product code DSP·February 2, 2009

    Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc. Model: IAB-05840-U

    FDA Recall
    Terminated ·Arrow International, Inc., Division of Teleflex Medical Inc.·Product code DSP·October 11, 2010

    Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 30cc. Model: IAB-05830-U

    FDA Recall
    Terminated ·Arrow International, Inc., Division of Teleflex Medical Inc.·Product code DSP·October 11, 2010

    Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)

    FDA Recall
    Terminated ·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·January 30, 2015

    Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

    FDA Recall
    Terminated ·Arrow International, Inc., Division of Teleflex Medical Inc.·Product code DSP·February 10, 2016

    AutoCAT 2 Series Intra-Aortic Balloon Pumps Catalog No: IAP-0400, IAP-0435, IAP-0500, and IAP-0535, Arrow International, Everett, MA 02149

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·November 12, 2007

    CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code DSP·March 27, 2012

    Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.

    FDA Recall
    Terminated ·Datascope Corporation·Product code DSP·February 21, 2018

    CS 100 Intra-Aortic Balloon Pump

    FDA Recall
    Terminated ·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·June 16, 2017

    Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20 Software Version: Not applicable Product Description: The Insightra Ultra IABP Catheter Kit is a 7 French catheter available with either a 40, 35, 30, 25, or 20 cc balloon. The catheter has two lumens and is designed to provide counterpulsation cardiac assist therapy. The outer lumen is a channel for helium used to inflate and deflate the balloon. The inner lumen is used for a guidewire and blood pressure measurement. It is packaged as a convenience kit with accessories (one-way valve, 50 cc syringe, guide wires, introducer needle, dilator, pressure tubing, Datascope & Arrow adaptors). The balloon inflation and deflation cycle is synchronized (using a commercially available control console) with the ECG or arterial pressure to provide counterpulsation synchronized with the heartbeat. It is intended to increase coronary perfusion, decrease the workload of the left ventricle and allow healing of the myocardium Component: No

    FDA Recall
    Terminated ·Insightra Medical Inc·Product code DSP·July 19, 2025

    8 Fr 40cc Narrow Flex IAB Catheter Kit with Generic Adapters Product Number: IAB-04840-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.

    FDA Recall
    Terminated ·Arrow International, Inc.·Product code DSP·February 2, 2009