Welch Allyn KleenSpec Corded Illuminator Recalled for Electric Shock Risk
Welch Allyn is recalling KleenSpec Corded Illuminators because they may be connected to AC power, posing a shock hazard.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a potential electric shock hazard, which constitutes a significant injury risk under the rubric for Severe (Score 4) recalls.
Plain-English summary
Welch Allyn Inc is recalling the KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model Number 78x Series Illuminator. The recall covers specific catalog numbers including 78800, 73410, 73412, 73414, 73416, 78810, 78812, 78814, and 78816.
The firm determined that the illuminator has the potential to be incorrectly connected to a commonly available AC power cord instead of the low-voltage transformer power cord supplied with the device. This incorrect connection may result in a shattered lamp bulb and a potential electric shock hazard.
The recall affects 179,401 units distributed domestically and 15,063 units distributed to foreign countries. The products were distributed nationwide, in Puerto Rico, and to various international locations. Consumers should stop using the affected devices and contact Welch Allyn for instructions on the recall.
The recalled product
- Product
- 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
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all lots
Distribution
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