Welch Allyn KleenSpec Corded Illumination System recall
Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model Number 78x Series Illuminator, REF 901070, Catalog Numbers…
Why was Welch Allyn KleenSpec Corded Illumination System recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
all lots
- Product
- Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model Number 78x Series Illuminator, REF 901070, Catalog Numbers…
- Recalling firm
- Welch Allyn Inc
- Quantity
- Domestic: 179,401 units, Foreign: 15,063 units
- 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.
- Recall date
- November 4, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)