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U.S. Department of Health and Human Services

Class 2 Device Recall Welch Allyn KleenSpec Corded Illumination System

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  Class 2 Device Recall Welch Allyn KleenSpec Corded Illumination System see related information
Date Initiated by Firm October 02, 2015
Date Posted October 30, 2015
Recall Status1 Terminated 3 on May 23, 2018
Recall Number Z-0169-2016
Recall Event ID 72228
510(K)Number K120743  
Product Classification Speculum, vaginal, nonmetal - Product Code HIB
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
Code Information all lots
Recalling Firm/
Manufacturer		 Welch Allyn Inc
4341 State Street Rd
Skaneateles Falls NY 13153-5300
For Additional Information Contact Jamie Arnold
315-685-4599
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HIB and Original Applicant = WELCH ALLYN, INC.
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