Events

Recall of Welch Allyn KleenSpec Corded Illumination System

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

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
    72228
  • Event Risk Class
    Class 2
  • Event Number
    Z-0169-2016
  • Event Initiated Date
    2015-10-02
  • Event Date Posted
    2015-10-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140278
  • 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
    Speculum, vaginal, nonmetal - Product Code HIB
  • Reason
    The firm became aware that the kleenspec¿ 788 corded illuminator has the potential to be incorrectly connected to a commonly available ac power cord instead of the illuminator low voltage transformer power cord which is supplied with the illuminator. this may result in a shattered lamp bulb and a potential electric shock hazard.
  • Action
    On 10/02/2015, Welch Allyn commenced mailing of the Urgent Medical Device Correction letters (dated 10/01/2015) via UPS Certified Next Day Air Saver Mail. Welch Allyn then issued a 2nd notice dated 10/16/2015 to include an additional five (5) catalog numbers impacted by the issue. The letters inform customers of the issue and help customers avoid any such occurrences. Welch Allyn is provided supplementary User Precautions which re-emphasize safe use of this product and providing additional specificity to the warnings already on the labeling and packaging.

Device

Welch Allyn KleenSpec Corded Illumination System
  • Model / Serial
    all lots
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Puerto Rico and foreign distribution to the following countries: Australia, Bahamas, Bahrain, Belgium, Bermuda, Cambodia, Canada, Czech Republic, China, Cyprus, Denmark, Egypt, France, Germany, Great Britain, Greece, Guam, Guatemala, Iceland, India, Israel, Japan, Kenya, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sri Lanka, Thailand, Turkey, United Arab Emirates.
  • Product Description
    Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model Number 78x Series Illuminator, REF 901070, Catalog Numbers 78800, 73410, 73412, 73414, 73416, 78810, 78812, 78814 and 78816, Rx ONLY
  • Manufacturer
    Welch Allyn Inc

Manufacturer

Welch Allyn Inc
  • Manufacturer Address
    Welch Allyn Inc, 4341 State Street Rd, Skaneateles Falls NY 13153-5300
  • Manufacturer Parent Company (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA