Acclarent, Inc. recalls TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
- Recall date
- March 6, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0826-2020
- FDA classification
- Class II
- Brand / firm
- Acclarent, Inc.
- Sold / distributed
- US: WI, IL, NE, CA, OH, NY OUS: None
Why it was recalled
The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
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