Device manufacturer Pentax voluntary recalled its ED-3490TK model duodenoscopes Wednesday, according to an FDA safety communication.
Here are three things to know.
1. Pentax recalled the device to make design changes to reduce the likelihood of patient fluid leaking into the closed elevator channel beneath the distal cap. The company will also update the device's operation manual to include recommendations for annual maintenance.
2. The FDA on Wednesday approved Pentax's updated design and labeling changes to the ED-3490TK.
3. After reviewing reprocessing instructions established for the device in February 2016, the FDA "continues to recommend that facilities using Pentax ED-3490TK duodenoscopes train staff on the updated instructions and implement them, if they have not already done so."
To read the full FDA safety communication, click here.
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