Events

Recall of Device Recall AquaPak Sterile Water for Inhalation, USP, 760 mL

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
    34120
  • Event Risk Class
    Class 2
  • Event Number
    Z-0503-06
  • Event Initiated Date
    2005-12-01
  • Event Date Posted
    2006-02-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43154
  • 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
    Teleflex medical determined that the distribution center shipped unreleased product which did not pass validated sterility test requirements.
  • Action
    Teleflex Medical sent recall letters dated 12/1/05 to their direct accounts on the same date via UPS overnight. The accounts were informed that the lot did not pass validated sterility test requirements, and were instructed to cease distribution and use of the lot and quarantine it for return to Teleflex Medical, Durham, NC. The wholesalers were requested to notify their customers of the recall and have them return their inventory of the lot to the direct account for consolidation and return to Teleflex. Questions were directed to Dan Daily at 1-800-334-9751, ext. 4948.

Device

Device Recall AquaPak Sterile Water for Inhalation, USP, 760 mL
  • Model / Serial
    catalog number 037-00, lot 150150, exp. 2009-10
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Colorado, Nebraska, Oregon, Minnesota, California, Pennsylvania, Michigan, Louisiana, Oklahoma and Texas.
  • Product Description
    AquaPak Sterile Water for Inhalation, USP, 760 mL blow-molded plastic bottle for use with a respiratory gas humidifier; 10 bottles per case; manufactured by Hudson Respiratory Care, Inc., Temecula, CA 92589-9020 USA; catalog #037-00
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 2345 Waukegan Rd Ste 120, Bannockburn IL 60015-1580
  • Source
    USFDA