Integra NeuroSciences Implants, NeuroBalloon Catheter, Sterile/EO, Rx only, single use, latex free: Catalog Number 7CBD10
This recall has been terminated (originally issued September 22, 2010).
- Company
- Integra Lifesciences Corp.
- Recall Initiated
- July 2, 2010
- Posted
- September 22, 2010
- Terminated
- May 29, 2012
- Recall Number
- Z-2425-2010
- Quantity
- 338 units
- Firm Location
- Plainsboro, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Certain NeuroBalloon Catheters have the potential to improperly inflate or deflate under certain conditions.
Distribution
Nationwide, Canada, Taiwan and to Integra, Australia.
Lot / Code Info
Catalog number: 7CBD10, lot numbers: 1057983, 0158170, 0158391, 0158587, 0158739, 0159085, 0159411, 0159499, 0159938, 0161630, and 0161857.
Root Cause
Process design
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.