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.
This recall has been terminated (originally issued February 2, 2011).
- Company
- Vital Signs Colorado Inc.
- Recall Initiated
- December 20, 2010
- Posted
- February 2, 2011
- Terminated
- July 1, 2011
- Recall Number
- Z-1024-2011
- Quantity
- 2202 units
- Firm Location
- Englewood, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Battery which powers the laryngeal scope light may dislodge resulting in loss of illumination.
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
Lot / Code Info
Lot numbers; 5113Q, 5113R, 5113T, 5125Y, 5128F, 5129J, 5137P, 5139M, 5140P, 5144A, 5154V, 5154X, 5154Y, 5158K, 5161J, 5176T, 5180Z, 5182D, 5183L, 5184U, 5191X.
Root Cause
Device Design
Action Taken
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.