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U.S. Department of Health and Human Services

Class 2 Device Recall Greenlight II laryngeal scope handle and cartridge

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 Class 2 Recall
Greenlight II laryngeal scope handle and cartridge
see related information
Date Posted February 02, 2011
Recall Status1 Terminated on July 01, 2011
Recall Number Z-1024-2011
Recall Event ID 57464
Product Classification Laryngoscope, Rigid - Product Code CCW
Product Laryngoscope Handle, Reusable, Rx, Product Code 4558GSP or 4559LED, Vital Signs Colorado, Inc., 11039 E. Lansing Circle, Englewood, CO 80112. Used for tracheal tube intubations during anesthesia, intensive care, and emergency medical airway management.
Code Information Lot numbers; 5113Q, 5113R, 5113T, 5125Y, 5128F, 5129J, 5137P, 5139M, 5140P, 5144A, 5154V, 5154X, 5154Y, 5158K, 5161J, 5176T, 5180Z, 5182D, 5183L, 5184U, 5191X.
Recalling Firm/
Manufacturer
Vital Signs Colorado Inc.
11039 East Lansing Circle
Englewood, Colorado 80112-5909
Manufacturer Reason
for Recall
Battery which powers the laryngeal scope light may dislodge resulting in loss of illumination.
FDA Determined
Cause 2
DESIGN: Device Design
Action Healthcare Systems sent an URGENT MEDICAL DEVICE CORRECTION letter dated December 20, 2010, to all affected consignees advising them of the possible problem and giving them interim safety instructions until new battery cartridges were available. Customers were instructed to complete and return the Confirmation Form which was included with the letter. For information regarding this recall call 973-956-5300.
Quantity in Commerce 2202 units
Distribution Worldwide Distribution - USA including AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KY, MA, MN, MO, NH, NJ, NY, OH, OK, SC, TN, TX, WA, and WV and the countries of Australia, Belgium, Canada, Dominican Republic, Ecuador, Germany, Hong Kong, Latvia, New Zealand, Taiwan, Turkey, and the UK
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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