Events

Recall of Device Recall Hudson RCI Humidifier Adaptor, 040.

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
    70280
  • Event Risk Class
    Class 2
  • Event Number
    Z-1102-2015
  • Event Initiated Date
    2015-01-14
  • Event Date Posted
    2015-02-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132779
  • 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 packages may contain foreign material (black particles).
  • Action
    Teleflex sent and Urgent Medical Device Recall Notification letter dated January 14, 2015 to all affected customers. The letter identified the affect product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine any products with the affected catalog numbers and lot numbers. Customers were asked to complete and return the enclosed Recall Acknowledgement Form. For questions contact your local sales representative or Customer Service at 1-866-246-6990.

Device

Device Recall Hudson RCI Humidifier Adaptor, 040.
  • Model / Serial
    Product Code: 005-40, Lot numbers: 005135, 015135, 017135, 029135, 010135, 035135, 006145, 003135, 018135, 034135, 019135, 023135, 028135, 010145, 004145, 008135, 009145, 002145, 030135, 002135, 031135, 016135, 022135, 026135, 021135, 008145, 032135, 007135, 004135, 007145, 009135, 027135, 001145, 005145, 012135, 006135, 020135, 033135, 013135, 001135, 011135, 036135, 025135, 014135 & 003145.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - U.S. Nationwide and the countries of: Australia, Bahrain, Belgium, Bermuda, Brazil, Canada, China, Ecuador, Germany, Great Britain, Hong Kong, Indonesia, Japan, Jordan, Malaysia, Mexico, New Zealand, Philippines, Singapore, South Korea, Saudi Arabia, Taiwan, Thailand, Uruguay and Zambia.
  • Product Description
    AQUA 540 SW, 540 W/040 ADAPTOR. || Product Usage: || The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA