Z-1740-2015 Class III Terminated
FDA device recall Z-1740-2015 was initiated by Acclarent, Inc. on April 28, 2015 and is designated Class III. Reason for recall: Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date. The recall status is terminated (terminated June 10, 2015). Affected quantity: 986.
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2015
- Initiation Date
- April 28, 2015
- Termination Date
- June 10, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 986
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.
Distribution Pattern
US in the state of Texas
Code Information
Catalog number GC070RF, Lot 120709i-cm, Expiry 7/31/2014.