Z-0169-2016 Class II Terminated
FDA device recall Z-0169-2016 was initiated by Welch Allyn Inc on October 2, 2015 and is designated Class II. 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 … The recall status is terminated (terminated May 23, 2018). Affected quantity: Domestic: 179,401 units, Foreign: 15,063 units.
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
Reason for Recall
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.