BEUDAMED
    FDA Recall Terminated

    Newport HT50 Ventilator. Model No. HT50-H, HT50-HB, HT50-H1, and HT50-H1B. The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 Ibs)

    Recall: Z-2382-2011 · Initiated May 14, 2010

    Recall

    Recall Number
    Z-2382-2011
    Event Number
    58629
    Firm
    Newport Medical Instruments Inc
    FEI Number
    2023050
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 14, 2010
    Posted
    May 26, 2011
    Terminated
    June 1, 2011
    Address
    1620 Sunflower Ave, Costa Mesa, CA, 92626-1513

    Description

    Newport HT50 Ventilator. Model No. HT50-H, HT50-HB, HT50-H1, and HT50-H1B. The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 Ibs)

    Reason

    The recall was initiated because Newport Medical has confirmed that the Newport HT50 hard shell Emergency Preparedness (EP) Storage Cases must be relabeled to caution users to follow current labeling guidelines for charging the battery for 8 hours but not longer than 24 hours at any one time.

    Action

    Newport Medical sent an FIELD CORRECTION NOTICE to all affected customers dated May 14, 2010. The letter identified the product, the problem and the action needed to be taken by the customer. Newport Medical also provided a revised labeling for the Emergency Preparedness (EP) Storage Case and an instruction sheet describing where to apply the new labels. Customers were instructed with the information that all the EP storage cases must be relabeled to caution users to follow current labeling guidelines for charging the battery for 8 hours but not longer than 24 hours at any one time. Customers were instructed to complete the attached acknowledgement form and fax it to " [email protected] " Customers with any questions should call Technical Support Department at (800) 451-3111 for US customers, and (714)427-5811 x500 for international customers.

    Distribution

    Worldwide Distribution -- USA including states of PA, TX, AK, GA, CA, MD, KY, FL, VA, LA, NC, OK and countries of Canada, Colombia, Armenia and Japan.

    Quantity

    1,113 EP cases