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Terminated

Hydrophobic HALO360 Filter that is packaged with HALO360+ Ablation Catheters Model numbers 32041-22, 32041-28, 32041-31 and 32041-34, and/or with HALO360 Sizing Balloon Model number 3441B.

FDA Recall Z-0192-2009 · Posted 2008-10-31

Recalling FirmBarrx Medical, Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2008-09-18
Date Terminated2011-04-26
Product Quantity650 units

Reason for Recall

Some units may contain the wrong filter, which does not have the proper lock and may result in a leak.

Firm Action

The recall was initiated on September 18, 2008. All users and international distributors were informed by letter. The replacement filters were sent on 9/19/2008. Contact Barrx Medical, Inc. at 1-408-745-8000 for assistance.

Root Cause

Mixed-up of materials/components

Distribution Pattern

Worldwide Distribution, including USA, Austria, Australia, Belgium, Canada, France, Netherlands, Switzerland, Sweden, and UK .

Official Source

View FDA Recall →

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

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