Recall Z-2130-2014— Teleflex Medical

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2014-06-30, terminated 2017-03-21. FDA's recall record names no specific 510(k) clearance for this event. Product: RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed by: Teleflex Medical.. Reason: There is a possibility the handle of the laryngoscope may heat up and melt the end cap..

Recalling firm
Teleflex Medical
Classification
Class II
Status
Terminated
Initiated
2014-06-30
Terminated
2017-03-21
Firm location
Durham, NC, United States

Product description

RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed by: Teleflex Medical.

Reason for recall

There is a possibility the handle of the laryngoscope may heat up and melt the end cap.

Data sourced from openFDA. This site is unofficial and independent of the FDA.