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Acclarent, Inc. recalls TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
Recalled January 29, 2020 · FDA recall Z-0825-2020 · Acclarent
Hazard
The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. · FDA Class II
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US: WI, IL, NE, CA, OH, NY OUS: None
Description
The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
Product
TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
Manufacturer(s)
Acclarent, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →