Events

Recall of Device Recall Steris

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

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
    73009
  • Event Risk Class
    Class 2
  • Event Number
    Z-1180-2016
  • Event Initiated Date
    2015-12-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142726
  • 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
    The firm discovered that one of the hysteroscope models listed for processing in four existing quick connects has one inlet port rather than two inlet ports as indicated in the quick connect processing instructions.
  • Action
    On 1/18/2016 the firm sent Voluntary Field Correction NOtices to their customers.

Device

Device Recall Steris
  • Model / Serial
    All Lots. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US nationwide, Australia, Bahrain, Bulgaria, Canada, Greece, Italy, Malaysia, Mexico, Qatar, Russia, Spain, and United Kingdom.
  • Product Description
    Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow unit consisting of tubing, tethers, and adapters. For sterilant and rinse water used in endoscope washers.
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Manufacturer Address
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060-1834
  • Manufacturer Parent Company (2017)
    Steris Corporation
  • Source
    USFDA