Commercial Name: Cannula Kit for Recurrent Stimulation with Stimulating Probe //// Anvisa Record: 10339190172 /// Risk Class: II. Affected model (s): 8229306, 8229307, 8229308 and Lot (s) / Serial number (s) affected: attached document. 의 안전성 경고

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Recommendations to Users and Patients: 1) Thoroughly inspect the cannula, including the cuff, wires and distal tip to ensure that all cannula components are secure and in place; and inflate the cuff with 15-20 cc of air to check for leaks; [Be sure to remove all air before intubation]. 2) Use standard fixed (non-malleable) probes matching the maximum to the natural curve of the tube; or, if a malleable probe is used, be careful to form a gradual curve in the probe that corresponds to the maximum to the natural curve of the tube and / or to allow the probe to slide easily into and out of the cannula. 3) DO NOT bend or flex excessively the cannula or electrodes prior to or during the intubation process. 4) Lubricate the cuff with a non-paralyzing aqueous lubricant for intubation; and use a lubricated probe. #### UPDATED ON 7/24/2017, the company submitted the completion report of the field action proving the sending of the security warning to the client.