Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Distributed: Worldwide distribution - US Nationwide.Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Distributed: Worldwide distribution - US Nationwide.Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Distributed: Worldwide distribution - US Nationwide.Reason: Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right position was previously selected, this may lead to unanticipated robotic arm positioning toward patient-left, may result in contact with patient/endotracheal tube.
Distributed: Worldwide - US Nationwide distribution in the states of MN, FL, NJ, NY, VA, WI, AZ, AL, MS, LA, MI, MA, MT, PA, WV, GA, DE, TX, CA, OH, IN, SC, CT, ND, MO, DC, IL, NE, ID, WA, NC, TN, OR, CO, SD, NM, VT, MD and the countries of Hong Kong, China, Canada.Reason: Firm is initiating a removal due to continued reports of adverse events.
Distributed: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.Reason: Firm is initiating a removal due to continued reports of adverse events.
Distributed: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.Reason: Firm is initiating a removal due to continued reports of adverse events.
Distributed: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.Reason: Firm is initiating a removal due to continued reports of adverse events.
Distributed: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.Reason: Firm is initiating a removal due to continued reports of adverse events.
Distributed: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.Reason: Firm is initiating a removal due to continued reports of adverse events.
Distributed: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.