Integra NeuroSciences Implants, NeuroBalloon Catheter, Sterile/EO, Rx only, single use, latex free: Catalog Number 7CBD1
FDA device recall Z-2425-2010 · posted 2010-09-22 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp
- Reason for recall
- Certain NeuroBalloon Catheters have the potential to improperly inflate or deflate under certain conditions.
- Action taken
- All customers and Integra Sales Specialists were notified of the recall on July 2, 2010 by fax, e-mail and letter send by Fed Ex overnight delivery.
- Root cause
- Process design
- Status
- Terminated
- Product code
- HAO
- Quantity affected
- 338 units
- Distribution
- Nationwide, Canada, Taiwan and to Integra, Australia.
- Date initiated
- 2010-07-02
- Date posted
- 2010-09-22
- Date terminated
- 2012-05-29
- Location
- Plainsboro, NJ
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