American Dental Tech Blog

Category Archives: Industry

  • FDA Announces Recall of the 980 Ventilator System

    Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall: Software Issue May Stop Ventilator

    The FDA has notified health professionals and their medical care organizations of the Class 1 recall of the Puritan Bennett 980 Ventilator Systems with software versions below 2.8, with distribution dates March 3, 2014 through August 22, 2014 and serial numbers listed here. The recalled products have a software problem that causes the ventilator to stop working after the air and oxygen gas supply lines are disconnected and then reconnected, which could lead to serious health problems or death.

    RECOMMENDATION: Covidien sent an Urgent Field Corrective Action letter dated October 3, 2014 to its customers. A Covidien representative will update the software on the ventilators as soon as possible. To receive the software update, complete the acknowledgement and receipt form attached to the correction letter. Fax it to the Covidien contact found on the form.

    Customers may continue to use these ventilators until Covidien updates the software, as long as two gas sources are connected to the ventilator at all times. See the recall notice at the link below for other Covidien reminders and instructions from the Corrective Action letter.

    Read the MedWatch safety alert including a link to the Recall Notice at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm422362.htm

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
  • FDA Announces Recall of Pediatric Breathing Circuits

    Hudson RCI Pediatric Anesthesia Breathing Circuits by Teleflex Medical: Class I Recall - Circuit Ends May Crack or Break

    The FDA has announced a report that the ends of the Hudson RCI Anesthesia Breating Circuits may crack or break before or during use. This could cause serious health risks, including delayed patient treatment, breathing difficulties, or death if not replaced immediately.

    Manufacturing Dates:  March 2013 to July 2014
    Distribution Dates:  June 2013 to May 2014

    RECOMMENDATION: On September 8, 2014, Teleflex Medical sent customers an Urgent Medical Device Recall letter explaining the device problem and actions to be taken. See complete list of recalled devices.

    Teleflex Medical recommends the following actions:

    • Stop using the devices.
    • Remove the devices from inventory and stop distribution.
    • Return the Recall Acknowledgement Form included with the letter.
    • Notify any customers who may have received the devices through re-distribution.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

    http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm417868.htm

  • FDA Announces Recall of Lidocaine HCL

    Hospira, Inc. is recalling one lot of Lidocaine HCI Injection, USP, 2%, 20 mg per mL, 5 mL single-Dose Vial, Preservative-Free (NDC 0409-2066-05; Lot 25-550-DD, Expiry 1JAN2015) to the user level due to a confirmed customer report of discolored product with visible particles in the solution as well as particulate embedded in the molded glass container. Hospira has identified the particulate as iron oxide.

    Check the lot numbers of your inventory to see if you have any affected product and contact Hospira or your dealer for instructions on exchanging the affected product.