Hydrophobic HALO360 Filter that is packaged with HALO360+ Ablation Catheters Model numbers 32041-22, 32041-28, 32041-31
FDA device recall Z-0192-2009 · posted 2008-10-31 · Terminated
Recall details
- Recalling firm
- Barrx Medical, Inc.
- Reason for recall
- Some units may contain the wrong filter, which does not have the proper lock and may result in a leak.
- Action taken
- 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
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 650 units
- Distribution
- Worldwide Distribution, including USA, Austria, Australia, Belgium, Canada, France, Netherlands, Switzerland, Sweden, and UK .
- Date initiated
- 2008-09-18
- Date posted
- 2008-10-31
- Date terminated
- 2011-04-26
- Location
- Sunnyvale, CA
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