Recalls / —
—#92899
Product
Integra NeuroSciences Implants, NeuroBalloon Catheter, Sterile/EO, Rx only, single use, latex free: Catalog Number 7CBD10
- FDA product code
- HAO — Instrument, Surgical, Non-Powered
- Device class
- Class 1
- Medical specialty
- Neurology
- Affected lot / code info
- Catalog number: 7CBD10, lot numbers: 1057983, 0158170, 0158391, 0158587, 0158739, 0159085, 0159411, 0159499, 0159938, 0161630, and 0161857.
Why it was recalled
Certain NeuroBalloon Catheters have the potential to improperly inflate or deflate under certain conditions.
Root cause (FDA determination)
Process design
Action the firm took
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.
Recalling firm
- Firm
- Integra LifeSciences Corp
- Address
- 105 Morgan Ln, Plainsboro, New Jersey 08536-3339
Distribution
- Distribution pattern
- Nationwide, Canada, Taiwan and to Integra, Australia.
Timeline
- Recall initiated
- 2010-07-02
- Posted by FDA
- 2010-09-22
- Terminated
- 2012-05-29
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #92899. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.