ClearanceBrief
Recall Z-2130-2014 ยท CCW Laryngoscope, Rigid

Teleflex Medical

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

DateJul 29, 2014 (initiated Jun 30, 2014)
StatusTerminated
ReasonThere is a possibility the handle of the laryngoscope may heat up and melt the end cap.
Root causeDevice Design
ActionConsignees were notified via letter on/about 06/30/2014.
Quantity6,246 units
DistributionU.S. Nationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.