Recall Z-1740-2015— Acclarent, Inc.
Class III · Terminated
Class III FDA medical device recall by Acclarent, Inc., initiated 2015-04-28, terminated 2015-06-10. FDA's recall record names no specific 510(k) clearance for this event. 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. .. Reason: Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date..
- Recalling firm
- Acclarent, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2015-04-28
- Terminated
- 2015-06-10
- Firm location
- Menlo Park, CA, United States
Product description
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. .
Reason for recall
Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.
Data sourced from openFDA. This site is unofficial and independent of the FDA.