Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea). Model Numbers: ENF-T3, ENF-VT2, ENF-VT3.

Reason: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

Code information: Model Number (UDI-DI): ENF-T3 (04953170307188), ENF-VT2 (04953170339509), ENF-VT3 (04953170411526).

Distribution pattern: Worldwide - US Nationwide distribution.