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Terminated

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

FDA Recall Z-0169-2016 · Posted 2015-10-30

Recalling FirmWelch Allyn Inc
Recall StatusTerminated
Product CodeHIB
Date Initiated2015-10-02
Date Terminated2018-05-23
Product QuantityDomestic: 179,401 units, Foreign: 15,063 units

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.

Firm Action

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

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120743SPECULUM, VAGINAL, NONMETALWelch Allyn, Inc. · 2012-03-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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