Acclarent Recalls TruDi NAV Suction Instruments Due to Calibration Issues
Acclarent, Inc. is recalling specific lots of TruDi NAV Suction Instruments because calibration issues cause incorrect tip orientation displays.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The defect involves a display calibration error rather than a direct physical hazard like a broken component or contamination, fitting the criteria for moderate severity.
Plain-English summary
Acclarent, Inc. is recalling three lots of TruDi NAV Suction Instruments (TDNS070Z, 70 Degree Tip Angle) due to calibration issues. The defect causes the system to display incorrect tip orientation information.
The recalled lots are 1901080, 1901177, and 1901219. These instruments have a shelf life of 30 reprocessing cycles. The products were distributed in Wisconsin, Illinois, Nebraska, California, Ohio, and New York.
Healthcare facilities should stop using the affected instruments and contact Acclarent, Inc. for further instructions.
The recalled product
- Product
- TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
- Manufacturer
- Acclarent, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 1901080
- 1901177
Distribution
Part of a larger recall action
This product is one of 3 recalled by Acclarent, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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