BEUDAMED
    FDA Recall Terminated

    DeRoyal (R) Heat/Moist Exchange, REF 83-000042, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA: Intended Use: Varies by kit; an anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.

    Recall: Z-0016-2012 · Initiated August 23, 2011

    Recall

    Recall Number
    Z-0016-2012
    Event Number
    59854
    Firm
    Deroyal Industries, Inc. Lafollette
    FEI Number
    3005011024
    Product Code
    OFD
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 23, 2011
    Posted
    October 6, 2011
    Terminated
    January 30, 2013
    Address
    1501 East Central Ave La, Follette, TN, 37766-2892

    Description

    DeRoyal (R) Heat/Moist Exchange, REF 83-000042, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA: Intended Use: Varies by kit; an anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.

    Reason

    The firm manufactured kits containing a HCH device, manufactured by Vital Signs, that was subsequently recalled because the product may have an occlusion that could prevent proper flow of medical gases or oxygen to the patient.

    Action

    The firm, DeRoyal, sent a "URGENT: MEDICAL DEVICE RECALL" letter dated September 13, 2011 to its customers. The letter describes product, problem, and actions to be taken. Customers are instructed to identify inventory being recalled and place in quarantine to prevent further use. Constomers were asked to return affected product they have in inventory. DeRoyal will replace this product free of charge. Customers were asked to complete the attached Recall Response Spreadsheet and return as per the instructions. Constomers were asked to return affected product they have in inventory. DeRoyal will replace this product free of charge. Distributors were instructed to perform a sub-recall to their customers. Customers with questions should call 865-362-1037 between 9am and 5pm EST or email [email protected].

    Distribution

    Nationawide Distribution USA - including the states of: CA, FL, GA, NJ, and WA.

    Quantity

    200 units