American Dental Tech Blog

Category Archives: Industry

  • 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.

  • FDA Announces Recall of Manual Resuscitators

    The FDA has released a notice of recall of Ventlab brand manual resuscitators due to a possibility the duckbill valve will stick. Thish can lead to complications including hypoxia in patients when the bag is used. Only a limited number of bags were affected, primarily those designed for pediatric use.

    If you have a Ventlab brand resuscitator in your office, contact the manufacturer to see if your bag is affected by the recall. They also have a full list of affected serial numbers and dates of manufacture available.

    For additional information, you can see the FDA's announcement here.