Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1024-2011

Laryngoscope Handle, Reusable, Rx, Product Code 4558GSP or 4559LED, Vital Signs Colorado, Inc., 11039 E...

Vital Signs Colorado, Inc. / initiated 2010-12-20 / Terminated / root cause: design

Vital Signs Colorado Inc. began a recall of Laryngoscope Handle, Reusable, Rx, Product Code 4558GSP or 4559LED, Vital Signs Colorado, Inc., 11039 E. Lansing Circle, Englewood, CO 80112. Used for tracheal... on . The reason FDA records is "Battery which powers the laryngeal scope light may dislodge resulting in loss of illumination". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1024-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Vital Signs Colorado, Inc.
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.
Product code
CCW Laryngoscope, Rigid
Reason for recall
Battery which powers the laryngeal scope light may dislodge resulting in loss of illumination.
Root cause tag
design
FDA 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 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
Product codes and lots
Lot numbers; 5113Q, 5113R, 5113T, 5125Y, 5128F, 5129J, 5137P, 5139M, 5140P, 5144A, 5154V, 5154X, 5154Y, 5158K, 5161J, 5176T, 5180Z, 5182D, 5183L, 5184U, 5191X.