OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.

Reason: The potential for unsterilized product within finished product labeled as sterile.

Code information: UPN: AC-2003748; UDI-DI: 07290109142807; Batch Numbers: 32644549 and 32769567; Expiration Date: 22Aug2025;

Distribution pattern: Domestic: PA, WI; International: Germany, India;