Acclarent, Inc. recalls RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a…
- Recall date
- April 28, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1740-2015
- FDA classification
- Class III
- Brand / firm
- Acclarent, Inc.
- Sold / distributed
- US in the state of Texas
Why it was recalled
Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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. .
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