Z-0169-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 4, 2015
- Initiation Date
- October 2, 2015
- Termination Date
- May 23, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Domestic: 179,401 units, Foreign: 15,063 units
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
Reason for Recall
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.
Distribution Pattern
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.
Code Information
all lots