BEUDAMED
    33 results · 26ms · Sources: EU EUDAMED, US FDA

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    Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra¿ Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·June 12, 2019

    Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code BTO·February 11, 2019

    NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.

    FDA Recall
    Terminated ·Blue Belt Technologies MN·Product code OLO·April 11, 2014

    NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.

    FDA Enforcement
    Class II ·Terminated·Blue Belt Technologies MN·May 21, 2014

    Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013

    Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013

    Cannulaide, Model 101. The Cannulaide product is composed of die-cut hydrocolloid coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface. The Cannulaide is applied under and over the nose of infants to provide a protective barrier to the philtrum, columella, septum, nares, and tip of nose. It is available in multiple sizes that vary the external geometry and nare hole size and spacing to allow for use on infants ranging from less than 700 grams to greater than 3000 grams. It is a non sterile, single patient use, disposable device.

    FDA Recall
    Terminated ·Beevers Manufacturing & Supply, Inc.·Product code BZD·January 18, 2007

    Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned.

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009

    Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FYA·May 23, 2013

    Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FYA·May 23, 2013

    Pediatric Manual Pulmonary Resuscitator. Product ID # 12-8708. Packaged under the name of Evergreen.

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009

    Unomedical Pediatric Manual Pulmonary Resuscitator, Child Mask & Reservoir Hose, Product ID # 779728

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009

    Unomedical Adult Manual Pulmonary Resuscitator, Adult Medium Mask w/ Reservoir Bag. Product ID # 779725

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009

    Unomedical Infant Manual Pulmonary Resuscitator, Infant Mask & Reservoir Hose. Product ID # 779733

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009

    Pediatric Manual Pulmonary Resuscitator w/Luer-lock Sampling Elbow & Reservoir bag (No mask). Product ID# 12-8707. Packaged under the name of Evergreen.

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009

    Infant Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas sampling elbow. Product ID # 12-8714; 731-E, 731MM; 86-731E. Packaged under the name of Evergreen, Hospitak and McKesson.

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009

    Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 Cm H2O Elbow. Product ID # 735-E; Distributed in France only: product code: 40-116735.

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009

    Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel Gas Sampling Elbow. Product ID #: 728-E.

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009

    Hospitak Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel gas sampling elbow. Foreign distribution only. Product code: 725-E,

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009

    Drager Medical Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and swivel gas sampling elbow, Peep Valve. Product code: 40-116733, Distribution to France only.

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009