Events

Recall of Device Recall Hudson RCI AQUA Flex, Hygroscopic Condenser Humidifier

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Teleflex Medical.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    55077
  • Event Risk Class
    Class 1
  • Event Number
    Z-1634-2010
  • Event Initiated Date
    2010-03-19
  • Event Date Posted
    2010-08-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89837
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
  • 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.

Device

Device Recall Hudson RCI AQUA Flex, Hygroscopic Condenser Humidifier
  • Model / Serial
    Catalog number-- 1570, Lot numbers: 200910, 200911, 200913, 200914, 200916, 200919, 200920, 200921, 200927, 200928, 200929, 200930, 200940, 200941, 200942, 200943, 200945, 200948 and 200951.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA