BEUDAMED
    FDA Recall Terminated

    Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable anaesthesia sets. Product Usage: The breathing bag is a component of the anesthesia set (breathing circuit) that is intended to is the conduit for administering medical gases to a patient during ventilation. It provides both an inspiratory and expiratory route. 2. The test lung is an apparatus that contains a breathing bag and and connector. It is connected to the output of a ventilator and is used as part of the device/system check out.

    Recall: Z-1452-2014 · Initiated March 25, 2014

    Recall

    Recall Number
    Z-1452-2014
    Event Number
    67808
    Firm
    Draeger Medical, Inc.
    FEI Number
    2517967
    Product Code
    BZO
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    March 25, 2014
    Posted
    April 10, 2014
    Terminated
    October 8, 2014
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    Description

    Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable anaesthesia sets. Product Usage: The breathing bag is a component of the anesthesia set (breathing circuit) that is intended to is the conduit for administering medical gases to a patient during ventilation. It provides both an inspiratory and expiratory route. 2. The test lung is an apparatus that contains a breathing bag and and connector. It is connected to the output of a ventilator and is used as part of the device/system check out.

    Reason

    Reusable latex breathing bags with various part numbers and sold as part of test lung and reusable anaesthesia sets were recalled when Draeger became aware of an incident where a user suffered an acute allergic reaction after using a Drger latex test lung. The user did not suffer permanent injury. The breathing bag that belongs to the test lung and other latex breathing bags are labelled NR. A

    Action

    A recall notification letter, dated March 2014, was sent to wholesale distributors and end users.

    Distribution

    USA Nationwide Distribution in the states of: MI, SC, CO, OH, NE, WI, NC, SD, AZ, TX, MA, WA, PA, KY, MN, GA, OK, NY, IN, VA, UT, MT, ME,FL, CA, MD, MO, IA, TN, MD, WV, IL,NJ, CT, and AR.

    Quantity

    433