Medical device recalls

Acclarent, Inc. recalls RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a…

Recall date
April 28, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1740-2015
FDA classification
Class III
Brand / firm
Acclarent, Inc.
Sold / distributed
US in the state of Texas

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What 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. .

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