Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model Number 78x Series Illuminator,
FDA device recall Z-0169-2016 · posted 2015-10-30 · Terminated
Recall details
- Recalling firm
- Welch Allyn Inc
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HIB
- Quantity affected
- 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, Ger
- Date initiated
- 2015-10-02
- Date posted
- 2015-10-30
- Date terminated
- 2018-05-23
- Location
- Skaneateles Falls, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPECULUM, VAGINAL, NONMETAL (K120743) | Welch Allyn, Inc. | 2012-03-23 |