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

FDA device recall Z-1024-2011 · posted 2011-02-02 · Terminated

Recall details

Recalling firm

Vital Signs Colorado Inc.

Reason for recall

Battery which powers the laryngeal scope light may dislodge resulting in loss of illumination.

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.

Root cause

Device Design

Status

Terminated

Product code

CCW

Quantity affected

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

Date initiated

2010-12-20

Date posted

2011-02-02

Date terminated

2011-07-01

Location

Englewood, CO