Events

Recall of Device Recall Steris Quick Connect (tethered)

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
    25374
  • Event Risk Class
    Class 2
  • Event Number
    Z-0547-03
  • Event Initiated Date
    2003-03-07
  • Event Date Posted
    2003-02-06
  • 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=25694
  • 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 steris device may not attach properly to retrofitted olympus bronchoscopes, and become loose during the sterile processing cycle.
  • Action
    On 3/14/2002 by mail and 2/21/2003 by fax. The units will be replaced.

Device

Device Recall Steris Quick Connect (tethered)
  • Model / Serial
    Lot nos: 3508686 or smaller (C1406 and QLC1406); Lot nos: 3147303 or smaller (C1473 and QLC1473).
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. Some foreign distribution into Canada, Italy, Greece, Australia, New Zealand, UK, Brussels, Norway, Zaire, Spain, Behrain, Israel.
  • Product Description
    C1406, QLC1406, C1473, and QLC1473 Quick Connect for Olympus 30/40/160/200/240 Series Bronchoscopes in the C1140 Universal Processing Trays. Catalog numbers: C11473 and QLC1473.
  • Manufacturer
    Steris Corp

Manufacturer

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