Events

Recall of Device Recall QPC1680 Quick Connect

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
    28569
  • Event Risk Class
    Class 2
  • Event Number
    Z-0765-04
  • Event Initiated Date
    2004-03-15
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-05-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32144
  • 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
    Sterilant, Medical Devices - Product Code MED
  • Reason
    A defective port adapter may affect the sterilization process of the attached endoscope.
  • Action
    The firm contacted the consignees by letter and in person.

Device

Device Recall QPC1680 Quick Connect
  • Model / Serial
    Lots #2925196, #2911782, #2925238.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to domestic consignees in LA, NC, OH, CT, VA, CA, ME, MD, IL, PA, SC, WY, ND, NY, OK, TX. Foreign distribution involves: Canada, Italy, and Germany.
  • Product Description
    QPC1680 Quick Connect, for Pentax 30/40/K Series Two-Channel GI Endoscopes, in the Steris System 1 Sterile Processing System with the C1160 Universal Flexible Processing Tray, Cat No. QPT1680
  • Manufacturer
    Steris Corp

Manufacturer

Steris Corp
  • Manufacturer Address
    Steris Corp, 5960 Heisley Rd, Mentor OH 44060-1834
  • Source
    USFDA