Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1225-06

Green Spec Fiberoptic Laryngoscope Handle - Stubby/Short; a battery operated fiberoptic laryngoscope handle...

Teleflex Medical / initiated 2006-06-15 / Terminated

Teleflex Medical began a recall of Green Spec Fiberoptic Laryngoscope Handle - Stubby/Short; a battery operated fiberoptic laryngoscope handle for use with green coded fiberoptic systems and... on . The reason FDA records is "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". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1225-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Teleflex Medical
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
Product code
CCW Laryngoscope, Rigid
Reason for recall
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.
FDA root cause
Component change control
Action
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.
Quantity in commerce
1,408 laryngoscopes
Distribution
Nationwide and Canada, Colombia, Costa Rica and Chile.
Product codes and lots
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.