Series 400 Electronic Video Endoscope System - Duodenoscope (2019-01-24)
Recall Summary Pentax of America is recalling the Series 400 Electronic Video Endoscope System duodenoscope across Canada because the device may not be properly sterilized between uses, which could allow bacteria to remain on the equipment. This recall affects medical facilities that use this type of endoscope for examining the small intestine and bile ducts. The FDA classified this as a Class I recall, meaning there is a reasonable possibility that exposure to the device could cause serious adverse health consequences or death.
- Reason
- Medical devices
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2019-02-22
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/5d56080c-257a-487f-bd14-74b60140d76e