Brain Catheter Recall from Integra LifeSciences Announced
Posted Aug 24 2010 11:44am
There are just under 2000 units that were distributed in the US and overseas. In July customers were notified about the potential defect with the catheter. This is a class 1 recall, having the most potential harm.
As usual, a look up of catalog numbers, etc. is required and again my answer to that would be to have bar codes on the packaging and on the web. If in fact I were a patient having brain surgery I would concerned here.
Integra LifeSciences Corp. issued a global recall of its NeuroBalloon catheter.
The Plainsboro, N.J.-based holding company said it received a total of eight complaints, all from outside the U.S., regarding the inflation or deflation of the device.
Integra distributed 1,924 units in the U.S. and internationally, and it notified distributors and customers of the intracranial device about the possible defect July 2, the company said .
The catalog number of the recalled NeuroBalloon catheters is 7CBD10; the recall includes lot identifications 0157983, 0158170, 0158391, 0158587, 0158739, 0159085, 0159411, 0159499, 0159938, 0161630 and 0161857.