Acclarent Recalls TruDi NAV Suction Instruments Due to Calibration Issues
Acclarent, Inc. is recalling three 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 source text describes a calibration defect causing incorrect display but does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Acclarent, Inc. is recalling three lots of TruDi NAV Suction Instruments (TDNS090Z, 90 Degree Tip Angle). The recall involves specific lot numbers: 1901080, 1901177, and 1901219. These instruments have a shelf life of 30 reprocessing cycles.
The firm identified that the affected lots contain calibration issues that result in an incorrect tip orientation display within the system. This defect may affect the accuracy of the device's navigation feedback.
The recalled products were distributed in the United States to the states of Wisconsin, Illinois, Nebraska, California, Ohio, and New York. No distribution outside the United States is reported. Users should stop using the affected instruments and contact Acclarent, Inc. for further instructions.
The recalled product
- Product
- TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
- Manufacturer
- Acclarent, Inc.
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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