BEUDAMED
    FDA Recall Terminated

    Hudson RCI AQUA+ Flex, Hygroscopic Condenser Humidifier, HCH Tidal Volume Range 300-1500mL, ICU/Anesthesia Adult/Child, Catalog number 1570, Distributed by Teleflex Medical. The Aqua+ Flex is a passive humidifier indicated for use on patients under anesthesia and intensive care to effectively warm and humidify the inspired air.

    Recall: Z-1634-2010 · Initiated March 19, 2010

    Recall

    Recall Number
    Z-1634-2010
    Event Number
    55077
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    BTT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 19, 2010
    Posted
    August 13, 2010
    Terminated
    November 28, 2011
    Address
    4024 Stirrup Creek Dr, Durham, NC, 27703-9000

    Description

    Hudson RCI AQUA+ Flex, Hygroscopic Condenser Humidifier, HCH Tidal Volume Range 300-1500mL, ICU/Anesthesia Adult/Child, Catalog number 1570, Distributed by Teleflex Medical. The Aqua+ Flex is a passive humidifier indicated for use on patients under anesthesia and intensive care to effectively warm and humidify the inspired air.

    Reason

    The patient end of the 22 cm connector on the flex tube may not fit securely within the endotracheal tube (ET) connector and therefore disconnect from the endotracheal tube. A disconnect in ventilator dependent patients without prompt response to the alarm could lead to hypoxia, organ failure, or cardio-respiratory arrest.

    Action

    Teleflex Medical sent an Urgent Medical Device Recall letter on March 22, 2010 to consignees. They were instructed to: 1) Immediately discontinue use and quarantine any products labeled as AQUA+ FLEX, Catalog number 1570 with the lot numbers provided. 2) Complete and fax the Recall Acknowledgment Form to 866-804-9881. 3) After contact by a Customer Service Representative, who will provide them with a Return Goods Authorization Number, return the product to Teleflex Medical for credit. Letters addressed to distributors instructed them to communicate the recall to any of their customers who have received the product using the customer letter template and acknowledgement form provided by Teleflex Medical. Their customers were to return the product and acknowledgment form to the distributor who would consolidate and return the product to Teleflex Medical. Affected products received by Teleflex Medial will be destroyed upon receipt. For additional instructions or information, contact the firm at 1-866-246-6990.

    Distribution

    Worldwide distribution in the states of CA, FL, GA, KY, KS, IL, MA, MD, MI, MN, NC, NJ, NM, NY, OH, OK, OR, PA, RI, TN, TX, VA, and WI and to the country of Japan.

    Quantity

    3841 units