Recall Z-1024-2011 · CCW Laryngoscope, Rigid

Vital Signs Colorado Inc.

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.

Date	Feb 2, 2011 (initiated Dec 20, 2010)
Status	Terminated
Reason	Battery which powers the laryngeal scope light may dislodge resulting in loss of illumination.
Root cause	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	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
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.