FDAClass IIIJune 17, 2015

RELIEVA FLEX Sinus Guide Catheter F-70 recall

RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space…

Why was RELIEVA FLEX Sinus Guide Catheter F-70 recalled?

Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog number GC070RF, Lot 120709i-cm, Expiry 7/31/2014.

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…
Recalling firm
Acclarent, Inc.
Quantity
986
Distribution
US in the state of Texas
Recall date
June 17, 2015
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls