Device product
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. .
Z-1740-2015
Product summary
- Firm
- Acclarent, Inc.
- Event
- Event 71232
- Status
- Terminated
- Classification
- Class III
- Quantity
- 986
- Official record key
device-enforcement:Z-1740-2015
Official wording
Reason: Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.
Code information: Catalog number GC070RF, Lot 120709i-cm, Expiry 7/31/2014.
Distribution pattern: US in the state of Texas
Derived failure modes
-
Unknown
Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.