Recall Z-2425-2010 ยท HAO Instrument, Surgical, Non-Powered
Integra LifeSciences Corp
Integra NeuroSciences Implants, NeuroBalloon Catheter, Sterile/EO, Rx only, single use, latex free: Catalog Number 7CBD10
| Date | Sep 22, 2010 (initiated Jul 2, 2010) |
| Status | Terminated |
| Reason | Certain NeuroBalloon Catheters have the potential to improperly inflate or deflate under certain conditions. |
| Root cause | Process design |
| Action | 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. |
| Quantity | 338 units |
| Distribution | Nationwide, Canada, Taiwan and to Integra, Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.