FDAMarch 6, 2019device
TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
acclarent
UPCs
10705031245891
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDATruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC00052023-09-21
- FDATruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z2021-11-12
- FDATruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 107050312458842019-03-06
- FDATruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)107050312458772019-03-06
- FDARELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures. .2015-04-28
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