BEUDAMED
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    QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DTZ·October 25, 2018

    QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DTZ·October 25, 2018

    First Breath Adult Venturi Oxygen Mask with Corrugated Tubing, O2 Diluter Jets (6), Oxygen Tubing, and Nebulizer Hood. (Non-latex) 50/CA Reorder Number: 002610 For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more oxygen than is delivered via a standard nasal cannula (>6L/minute). During inspiration, the patient draws gases both from the oxygen flowing into the mask through the tubing as well as the room via ports on the sides of the mask. Oxygen concentration delivered is 40 60% depending on the patients breathing rate and tidal volume

    FDA Recall
    Terminated ·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BYF·February 11, 2011

    Mask adult, elastic strap style, Percent-O2 Lock air entrainment system, w/7' tube (Linde) - 50/cs; Salter Labs, Arvin, CA 93203 Intended usage: respiratory therapy.

    FDA Recall
    Terminated ·Salter Laboratories, Division of Regulatory Affairs·Product code BYF·March 25, 2011

    Value Pack General Anesthesia Kit, (containing Reorder Number: 001421 Oxygen Face Mask) Reorder Number: VP1302 For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more oxygen than is delivered via a standard nasal cannula (>6L/minute). During inspiration, the patient draws gases both from the oxygen flowing into the mask through the tubing as well as the room via ports on the sides of the mask. Oxygen concentration delivered is 40 60% depending on the patients breathing rate and tidal volume

    FDA Recall
    Terminated ·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BYF·February 11, 2011

    Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.

    FDA Enforcement
    Class II ·Terminated·Ormco/Sybronendo·December 9, 2015

    Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.

    FDA Enforcement
    Class II ·Terminated·Medtronic Vascular, Inc.·July 7, 2021

    Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.

    FDA Recall
    Terminated ·Medtronic Vascular, Inc.·Product code MIH·April 28, 2021

    Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.

    FDA Recall
    Terminated ·Ormco/Sybronendo·Product code DZC·November 4, 2015

    Multi Absorbers, reference number 8003138, in S/5 Aespire Start-up Kits (each containing 2 Multi Absorbers)

    FDA Recall
    Terminated ·Datex-Ohmeda·Product code BSF·February 12, 2003

    The IS Can Disposable CO2 absorber x 6 --- Carbon Dioxide absorbent for use on GE rebreathing systems --- Manufactured in the United Kingdom for: Intersurgical Incorporated --- 417 Electronics Parkway, Liverpool, NY 13088. Intended use: GE Healthcare anesthetic machines: S5 Aespire, S5 Avance, Aisys. The Intersurgical IS Can is for use with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane.

    FDA Recall
    Terminated ·Intersurgical Inc·Product code BSF·February 9, 2011

    Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finland Oy Made in US Rx Only The GE Healthcare Multi Absorber Original, Disposable is a disposable product intended for use with the GE Healthcare Advanced Breathing System (later ABS), the GE Healthcare EZchange manifold, the GE Healthcare Compact Block, and the GE Healthcare Compact Block II (later Compact Block). The Multi Absorber should only be used with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane. The device is intended to be used under constant attention of qualified professional healthcare personnel.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code BSF·September 19, 2013

    Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory Pressure (PEP) Therapy for patients who have Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems, and patients with atelectasis.

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code BWF·December 21, 2020

    GE Disposable Multi Absorber Canister used with EZchange Module for the Aisys, Avance, Aespire Anesthesia systems. The EZchange Module is an optional accessory for these anesthesia systems.

    FDA Recall
    Terminated ·Datex Ohmeda, Inc·Product code BSF·July 24, 2007

    Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.

    FDA Recall
    Terminated ·GETINGE US SALES LLC·Product code BSF·July 22, 2019

    Multi Absorbers, reference number 8003138

    FDA Recall
    Terminated ·Datex-Ohmeda·Product code BSF·February 12, 2003

    Curlin PainSmart Ambulatory Infusion Pump Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.

    FDA Recall
    Terminated ·Zevex International, Inc.·Product code FRN·February 28, 2011

    Curlin PainSmart IOD Ambulatory Infusion Pump Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.

    FDA Recall
    Terminated ·Zevex International, Inc.·Product code FRN·February 28, 2011

    Curlin 6000 IOD Ambulatory Infusion Pump Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.

    FDA Recall
    Terminated ·Zevex International, Inc.·Product code FRN·February 28, 2011

    Curlin 6000 CMS Ambulatory Infusion Pump Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.

    FDA Recall
    Terminated ·Zevex International, Inc.·Product code FRN·February 28, 2011