American Dental Tech Blog

Category Archives: News

News at American Dental Accessories

  • Recall of Lidocaine Announced

    Hospira, Inc. (NYSE: HSP), announced today it will initiate a voluntary recall of one lot of 1% Lidocaine HCI for Injection, USP, 10 mg per mL, 30 mL Single-dose, Preservative-Free (NDC 0409-4279-02; Lot 40-316-DK, Expiry 1APRIL2016) to the user level due to a confirmed customer report of particulate in a single unit. Hospira has identified the particulate as a human hair, embedded in and attached to a pinched area of the stopper.

    For detailed information pertaining to this Recall consult Hospira or the FDA.

  • 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 Surgical Convenience Packs

    The FDA has announced that Customed, inc. has issued a recall of its sterile convenience surgical packs, The products have been found to have an adhesion-related defect which can compromise the sterility of the product.

    Affected products have a manufacture date of 1/9/2009 through 5/19/2014.

    For additional information, see the FDA's notice or contact Customed at 1-787-801-0100 ext. 7540.