BEUDAMED
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    CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·April 17, 2019

    Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.

    FDA Enforcement
    Class II ·Terminated·NEO METRICS, INC.·June 18, 2014

    Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage: Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration, breathing pressure, respiratory volume, and anesthetic agent concentration and identification. It is an inhalation anesthesia machine for use in operating, induction, and recovery rooms. It can be used with rebreathing systems, semiclosed to virtually closed systems with low flow and minimal flow techniques, and non-rebreathing systems (with the Auxiliary Common Gas Outlet). It may be used with O2, N2O, and Air supplied by a medical gas pipeline system or by externally mounted gas cylinders. Anesthetic agent can be delivered via vaporizers mounted on the machine. The Apollo is equipped with a compact breathing system, providing fresh-gas decoupling, PEEP, and pressure limitation. It has an electrically driven and electronically controlled ventilator.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code BSZ·May 24, 2018

    Elan Diagnostics CHO ATAC Cholesterol Reagent Kit Product Number: 516-250

    FDA Recall
    Terminated ·Elan Diagnostics, Inc.·Product code CHH·November 7, 2002

    Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series machines are equipped with a compact breathing system; providing fresh gas decoupling, PEEP, and pressure limitation. The following ventilation options are available: Volume Controlled Ventilation Pressure Controlled Ventilation Pressure Support (Optional) SIMV/PS (Optional) Manual Ventilation Spontaneous Breathing Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2). As per IEC 60601-2-13 (Anesthetic Workstations and their Modules-Particular Requirements), additional monitoring of the concentrations of CO2 and anesthetic agent is required when the machine is in use. IEC 60601-2-13:2003 requires that a manual ventilation bag must be available for emergency use. Fresh gas enrichment is provided by the Drger Vapor anesthetic vaporizer. Fabius MRI can also be used in MRI scanner rooms with magnets 1.5 tesla and 3 tesla at a fringe field strength of 40 mtesla or less

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code BSZ·May 24, 2018

    Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series machines are equipped with a compact breathing system; providing fresh gas decoupling, PEEP, and pressure limitation. The following ventilation options are available: Volume Controlled Ventilation Pressure Controlled Ventilation Pressure Support (Optional) SIMV/PS (Optional) Manual Ventilation Spontaneous Breathing Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2). As per IEC 60601-2-13 (Anesthetic Workstations and their Modules-Particular Requirements), additional monitoring of the concentrations of CO2 and anesthetic agent is required when the machine is in use. IEC 60601-2-13:2003 requires that a manual ventilation bag must be available for emergency use. Fresh gas enrichment is provided by the Drger Vapor anesthetic vaporizer. Fabius MRI can also be used in MRI scanner rooms with magnets 1.5 tesla and 3 tesla at a fringe field strength of 40 mtesla or less

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code BSZ·May 24, 2018

    Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series machines are equipped with a compact breathing system; providing fresh gas decoupling, PEEP, and pressure limitation. The following ventilation options are available: Volume Controlled Ventilation Pressure Controlled Ventilation Pressure Support (Optional) SIMV/PS (Optional) Manual Ventilation Spontaneous Breathing Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2). As per IEC 60601-2-13 (Anesthetic Workstations and their Modules-Particular Requirements), additional monitoring of the concentrations of CO2 and anesthetic agent is required when the machine is in use. IEC 60601-2-13:2003 requires that a manual ventilation bag must be available for emergency use. Fresh gas enrichment is provided by the Drger Vapor anesthetic vaporizer. Fabius MRI can also be used in MRI scanner rooms with magnets 1.5 tesla and 3 tesla at a fringe field strength of 40 mtesla or less

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code BSZ·May 24, 2018

    O-Two Equinox Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000

    FDA Recall
    Terminated ·O-Two Medical Technologies, Inc.·Product code BZR·May 14, 2018

    D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. Product Usage: Water traps are intended to protect the GE monitor from humidity, secretions and bacterial contamination when monitoring respiratory parameters. D-fend and D-fend+ water traps are used with Compact gas module E-C(Ai)O(V)(X) and CardioCap/5 monitors. The Datex-Ohmeda S/5 Compact Airway Module, E-CAiOVX family is indicated for monitoring hospital patients respiration (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange status (Oxygen Consumption VO2, Carbon Dioxide production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE). Gas exchange status monitoring is not indicated in the presence of N2O+O2 mixtures. The device is indicated for use by qualified medical personnel only.

    FDA Recall
    Terminated ·GE Healthcare·Product code CCL·April 24, 2015

    O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000

    FDA Enforcement
    Class II ·Terminated·O-Two Medical Technologies, Inc.·August 29, 2018

    Perseus A500 Anesthesia Machine; Cat. no. MK06000 Product V Product Usage: Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressuresupported spontaneous breathing, and spontaneous breathing. Perseus is equipped with airway monitoring, gas measurement and device monitoring, O2 insufflation, and an anesthetic gas receiving system. Anesthesia is achieved through a mixture of pure oxygen and Air (medical compressed air) or pure oxygen and nitrous oxide, with the addition of volatile anesthetic agents. Ventilation is accomplished on the patient through a laryngeal mask airway, a full-face mask, or an endotracheal tube. The integrated breathing system can be used with partial rebreathing (low-flow or minimum-flow). A non-rebreathing system such as the Kuhn or Medec Water System may be used at the external fresh-gas outlet (optional). Perseus is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code BSZ·May 24, 2018

    CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code LXH·September 21, 2018

    Bag Tee Assembly Model P1407A . An accessory to the dental flowmeter which has a connection function for complete delivery of mixed gases to the breathing circuit portion of the gas scavenging apparatus. The Bag Tee assembly features a non-breathing valve and an Emergency Air Intake located on the bag tee which comply with the American Dental Association guidelines.

    FDA Recall
    Terminated ·Porter Instrument Co Inc·Product code CAX·August 26, 2008

    V-CATH Insertion Kits, Sterile; Product Code Number: 301-00; Manufactured by Centurion Medical Products for Neo Medical; 42514 Albrae Street, Fremont, CA 94538

    FDA Recall
    Terminated ·Neo Medical, Inc.·Product code LRS·April 5, 2011

    Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.

    FDA Recall
    Terminated ·NEO METRICS, INC.·Product code OCY·March 31, 2014

    Plicator EPS Plication System Catalog Number: 160-01128R

    FDA Recall
    Terminated ·NDO Surgical, Inc.·Product code KOG·January 26, 2007

    Passport 2 with View 12 ECG Analysis Module. It is a transportable, multi-parameter physiological monitor designed to monitor and display the following physiological parameters: ECG, Heart Rate derived from selected sources (Sp)2, ECG, IBP and NIBP), SpO2 level, ST Segment, Arrhythmia, Blood pressure (both invasive and non-invasive), Respiration rate (dirived from ECG or CO2), inspired or expired CO2, temperature , and gases (i.e. five anesthetsia gases, O2, N2O, and CO2)

    FDA Recall
    Terminated ·Datascope Corp·Product code DRT·September 7, 2005

    Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 is an accessory device designed to monitor airway gases during anesthesia and/or assisted respiration. Monitored gases includes O2, CO2, N2O and anesthetic agents Halothane, Isoflurane, Sevoflurane, Desflurane and Enflurane. It is intended for use in a fixed location such as the operating room or intensive care unit. The Gas Module 3 is compatible with Mindray patient monitors which display the gas analysis results through the use of a proprietary communication protocol.

    FDA Recall
    Terminated ·Mindray DS USA, Inc. dba Mindray North America·Product code BZK·December 1, 2017

    GE Healthcare, Uni-Circuit Kit, Adult, Disposable, 1.8 m/72 in, REF M1089028, M1087972, M1087975, M1126445, M1127508, M1127509, M1129780, M1129781, M1130230, M1137805, M1137199, M1145542, M1170604, M1151662, M1152224, M1158990, M1100486, M1122080, M1126444, M1163003, M1163255 M1132533, M1133966, M1170051, M1135144, M1139485, M1118627, M1118628, M1145406, M1147298, M1137811, M1152651, M1160275. pkg of 20 pcs, Latex Free. Breathing circuit for use with anesthesia machine or ventilator.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code CAI·June 5, 2009

    Datascope AS3000 Anesthesia System; Mindray, North America. The AS3000 Anesthesia Delivery System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor, provides for automatic and manual modes of ventilation, and is equipped with a monitoring system for ventilation, inspired and expired gas. The AS3000 is intended for use in operating rooms. It is used with O2, N2O and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Anesthetic agent can be delivered via vaporizers mounted on the machine.

    FDA Recall
    Terminated ·Mindray DS USA, Inc., dba Datascope Patient Monitoring·Product code BSZ·March 5, 2010