Reported Jun 17, 2015 · Terminated
RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a…
Acclarent, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Acclarent, Inc. · 1525B Obrien Dr · Menlo Park, CA · 94025-1463
Is this the product you have?
- 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. .
- Lot codes and dates
Catalog number GC070RFLot 120709i-cmExpiry 7/31/2014
- Amount recalled
- 986
Where it was sold
Why it was recalled
Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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