FDAApril 28, 2015device
RELIEVA 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. .
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.
What to do
FDA enforcement status: Terminated
Brands named
acclarent
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- 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, TDNS090Z, 90 Degree Tip Angle, (01) 107050312458912019-03-06
- FDATruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)107050312458772019-03-06
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