—#46584

Product

Green Spec Fiberoptic Laryngoscope Handle - Stubby/Short; a battery operated fiberoptic laryngoscope handle for use with green coded fiberoptic systems and single use laryngoscope blades; Teleflex Medical, Bannockburn, IL 60015; catalog number 004413300

FDA product code: CCW — Laryngoscope, Rigid
Device class: Class 1
Medical specialty: Anesthesiology
510(k) numbers: K883414
Affected lot / code info: catalog number 004413300, any lot number greater than and including 050901. Please note: the lot number is located at the top of the handle, where the laryngoscope hinge attaches to the blade.

Why it was recalled

Teleflex Medical has identified that the product may malfunction, causing the handle to heat up. There is a potential for the heated handle to burn the user.

Root cause (FDA determination)

Component change control

Action the firm took

Teleflex Medical sent Urgent Medical Device Recall letters dated 6/15/06 to the direct accounts, informing them of the potential for the handle to heat up, and requesting that they cease use of the affected units and return them to Teleflex Medical for replacement. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units being returned for replacement. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.

Recalling firm

Firm: Teleflex Medical
Address: 2345 Waukegan Rd, Ste 120, Bannockburn, Illinois 60015-1580

Distribution

Distribution pattern: Nationwide and Canada, Colombia, Costa Rica and Chile.

Timeline

Recall initiated: 2006-06-15
Posted by FDA: 2006-07-13
Terminated: 2009-08-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #46584. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.