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. .
Reported: June 17, 2015 Initiated: April 28, 2015 #Z-1740-2015
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.
Details
- Recalling Firm
- Acclarent, Inc.
- Units Affected
- 986
- Distribution
- US in the state of Texas
- Location
- Menlo Park, CA
Frequently Asked Questions
What product 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. .. Recalled by Acclarent, Inc.. Units affected: 986.
Why was this product recalled? ▼
Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 17, 2015. Severity: Low. Recall number: Z-1740-2015.
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