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Terminated

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. .

FDA Recall Z-1740-2015 · Posted 2015-06-09

Recalling FirmAcclarent, Inc.
Recall StatusTerminated
Product CodeKAM
Date Initiated2015-04-28
Date Terminated2015-06-10
Product Quantity986

Reason for Recall

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

Firm Action

Acclarent sent an Urgent Medical Device Recall letter dated May 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed that if the affected catheter is still in inventory, it should be isolated and returned to Acclarent per instructions. Questions should be addressed to Gabriel Alfageme, Field Action Coordinator at 1-650-687-5398.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US in the state of Texas

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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