The federal watchdog has cleared the updated design and labeling for the duodenoscope.
Hoya’s PENTAX Medical is recalling its ED-3490TK duodenoscopes looking to replace parts of the scopes to prevent leakage of patient fluids into the device, according to an FDA release.
The company is looking to replace the forceps elevator mechanism, o-ring seal and distal end covering to prevent leakage of fluids into the closed elevator channel and under the distal cap, according to the FDA release.
The federal watchdog said it cleared updated design and labeling for the duodenoscope, and that it is closely monitoring the association between so called ‘superbug’ outbreaks and the use of reprocessed endoscopes.
