BEUDAMED
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    Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.

    FDA Recall
    Terminated ·Nellcor Puritan Bennett Inc. (dba Covidien LP)·Product code CBK·October 1, 2014

    Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length and is designed for introduction and use through the appropriately sized Covidien" trocar sleeve or larger sized sleeve with the use of a converter. The atraumatic jaws are clamped and locked onto tissue structures by closing the handles

    FDA Enforcement
    Class II ·Terminated·COVIDIEN LLC·May 1, 2019

    Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number: 40000006

    FDA Enforcement
    Class I ·Terminated·Covidien LLC·October 22, 2014

    Covidien Kendall Adult Multi-Function Defibrillation Electrodes Part Number: 20660

    FDA Enforcement
    Class I ·Terminated·Covidien LLC·October 22, 2014

    Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R

    FDA Enforcement
    Class I ·Terminated·Covidien LLC·October 22, 2014

    Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.

    FDA Enforcement
    Class I ·Terminated·Nellcor Puritan Bennett Inc. (dba Covidien LP)·December 17, 2014

    Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC-S, 8FEN-S. Product Usage: The product is intended for use to bypass upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. The product is sold as sterile. The packaging may indicate either Covidien or Tyco as the manufacturer as the firm has transitioned from Tyco to Covidien over the past 4 years.

    FDA Enforcement
    Class I ·Terminated·Nellcor Puritan Bennett Inc. (dba Covidien LP)·August 22, 2012

    Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of gynecologic, general, urologic, thoracic and endoscopic procedures for temporary grasping/clamping of tissue and small tubular structures.

    FDA Enforcement
    Class II ·Terminated·COVIDIEN LLC·May 1, 2019

    CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # D190549.

    FDA Enforcement
    Class II ·Terminated·Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables·December 28, 2016

    Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length and is designed for introduction and use through the appropriately sized Covidien" trocar sleeve or larger sized sleeve with the use of a converter. The atraumatic jaws are clamped and locked onto tissue structures by closing the handles

    FDA Recall
    Terminated ·COVIDIEN LLC·Product code HDA·March 13, 2019

    BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.

    FDA Enforcement
    Class II ·Terminated·Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables·December 28, 2016

    Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor¿ Forehead SpO2Sensor, model RS10, is indicated for use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing more than 40 kg.

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·February 8, 2017

    Covidien Cytosponge Cell Collection Device. Item code CYTO-101-01. Gastroenterology: -.Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. This device is currently only being used in clinical studies.

    FDA Enforcement
    Class II ·Terminated·Covidien, LLC·July 13, 2016

    Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor Forehead SpO2Sensor, model RS10, is indicated for use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing more than 40 kg.

    FDA Recall
    Terminated ·Covidien LLC·Product code DQA·December 16, 2016

    SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Listing # A343147

    FDA Enforcement
    Class II ·Terminated·Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables·December 28, 2016

    Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection Device, Specimen Jar with preservative. Item code CYTO-KIT-R Gastroenterology: Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. Currently the device is only available for clinical studies.

    FDA Enforcement
    Class II ·Terminated·Covidien, LLC·July 13, 2016

    EYE KIT The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.

    FDA Enforcement
    Class II ·Terminated·Centurion Medical Products Corporation·April 12, 2017

    POST-OPERATIVE OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.

    FDA Enforcement
    Class II ·Terminated·Centurion Medical Products Corporation·April 12, 2017

    Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of gynecologic, general, urologic, thoracic and endoscopic procedures for temporary grasping/clamping of tissue and small tubular structures.

    FDA Recall
    Terminated ·COVIDIEN LLC·Product code HDA·March 13, 2019

    Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K

    FDA Recall
    Terminated ·Cardinal Health 200, LLC·Product code LYU·January 7, 2021