Events

Recall of Device Recall Quick Connects

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

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
    25946
  • Event Risk Class
    Class 2
  • Event Number
    Z-0724-03
  • Event Initiated Date
    2003-03-20
  • Event Date Posted
    2003-04-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26753
  • 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
    Sterilizer, Chemical - Product Code MLR
  • Reason
    The defective device may restrict the flow of sterilant to the attached endoscope and affect the sterilization process of the scope.
  • Action
    The firm contacted their affected consignees by telephone and letter on 3/20/2003.

Device

Device Recall Quick Connects
  • Model / Serial
    QFC1685 - Lots #3136314, #3136298, #3967981;  QFC1683 - Lot #3136330;  QFC1631 - Lot #4054870.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The devices were shipped to hospitals located in ME, NB, CA, IL, NJ, OH, IL, TX, MA, GA, MO, NC, and FL.
  • Product Description
    QFC1631, QFC1683, QFC1685 Quick Connects for use with Fujinon gastrointestinal endoscopes, for use with the STERIS SYSTEM I Processor and the C1160 Universal Flexible Processing Tray. || The QFC1631 is for Fujinon 450/485 Series Video Gastroscopes; || The QFC1683 is for Fujinon EC-450LP Colonoscopes; || The QFC1685 is for Fujinon 450/485 Series Video Colonoscopes with Water Jet;
  • Manufacturer
    Steris Corp

Manufacturer

Steris Corp
  • Manufacturer Address
    Steris Corp, 5960 Heisley Rd, Mentor OH 44060
  • Source
    USFDA