BEUDAMED
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    Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.

    FDA Recall
    Terminated ·LivaNova USA Inc·Product code LYJ·November 16, 2018

    Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.

    FDA Recall
    Terminated ·LivaNova USA Inc·Product code LYJ·November 16, 2018

    The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software Version 4.71. The AS 104 Blood Cell Separator Device has a Catalog Number 9007031. Used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS 104 Blood Cell Separator Device. This set is used with a single stage separation chamber.

    FDA Recall
    Terminated ·Fresenius Kabi, LLC·Product code LKN·April 19, 2011

    Kit: Blood Culture MAI Kit Part Number: 80076

    FDA Recall
    Terminated ·Medical Action Industries, Inc.·Product code OFZ·April 9, 2021

    OsteoPack 3 FZ 22cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

    FDA Recall
    Terminated ·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005

    GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.

    FDA Recall
    Terminated ·GE Healthcare·Product code IOL·March 12, 2015

    T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment consist of powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Specifically the T210 Treadmill is intended for use in Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.

    FDA Recall
    Terminated ·GE Medical Systems Ultrasound & Primary Care Diagnostics, LL·Product code IOL·April 2, 2018

    GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbers 408930-001 Rev E, 408930-002 Rev C, or 2028038-008 Rev B. Also Field Replaceable Unit P/Ns 408930-001 Rev E, 408930-002 Rev C. UPDATE: 3-30-2015: T2100 & T2000 Treadmills with power cord part numbers 408930-001, 408930-002, or 2028038-008 Also Field Replaceable Unit P/Ns 408930-001, 408930-002 Product Usage: Used for Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.

    FDA Recall
    Terminated ·GE Healthcare·Product code IOL·February 16, 2015

    GE Healthcare MAC 800 RESTING ECG ANALYSIS SYSTEM. The MAC 800 is a portable EGG acquisition, analysis and recording system. The MAC 800 is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages of 0 and 15 years. The MAC 800 is intended to be used by trained operators in a hospital or medical professional's facility environment to record EGG signals from surface electrodes. The basic system shall provide 2 modes of operation: (I) Resting EGG mode and (2) Arrhythmia mode. The basic systems shall print 3, 6-leads of EGG. The device shall be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code DPS·December 10, 2009

    Sierra Pre-Filled, Heparin Lock Flush Solution USP, 100 units/ml in 0.9% Sodium Chloride 120/Case, Catalog #1003-02, NDC #64054-1003-02, 5 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501

    FDA Recall
    Terminated ·AM2 PAT INC·Product code FOZ·December 11, 2007

    Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0903-12, NDC #64054-0903-2, 3 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501

    FDA Recall
    Terminated ·AM2 PAT INC·Product code FOZ·December 11, 2007

    Arrow ARROWg+ard Quad-Lumen CVCs (Central Venous Catheters)

    FDA Recall
    Terminated ·Arrow International Inc·Product code FOZ·February 11, 2009

    Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. (contains Q-Syte)

    FDA Recall
    Terminated ·Arrow International Inc·Product code FOZ·November 24, 2009

    BD Nexiva Closed IV Catheter System, REF 383536, 20GA 1.00IN, Becton Dickinson Infusion Therapy Systems Inc.

    FDA Recall
    Terminated ·Becton Dickinson Medical Systems·Product code FOZ·October 19, 2009

    Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 4.0 Fr/ 8cm, C-SDLMY-401J-ABRM-IHI-FST, G48047, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 4.0 Fr/5 cm, C-UDLMY-401J- PED-ABRM-HC-FST, G43992, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Double Lumen Polyurethane Catheter, 7.0 Fr/ 25 cm, C-UDLMY-801J-ABRM-HC-FST-A, G50819, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Spectrum Central Venous Catheter Tray, Minocydine/Rifampin Antibiotic Impregnated, Double Lumen, 7.5Fr/20cm, CUDLMY751JRSCABRMFST, G13482, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 4.0 Fr/ 5cm, C-UDLMY-401J-PED-ABRM-HC-IHI-FST, G48059, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated with Minipuncture Access, 8.0 Fr/ 15cm, C-UDLMY-801J-MNP-ABRM-HC-FST-A, G44069, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010