Z-1740-2015 Class III Terminated

Recalled by Acclarent, Inc. — Menlo Park, CA

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.