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.
FDA Publishes Information on How to Identify Recalls – Why Not Scan That Stent With A Cell Phone and Make It Easy for the Public and Manufacturers To Keep Up, Notify And Automate Compliance
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.
One story in particular involved a man who was implanted with a heart device that had been recalled and he died when it malfunctioned. To me, this could have been a preventable incident and a life could have been saved if a simple scan would have put up the red flags to not use the device. BD
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.
Integra LifeSciences recalls brain catheter | MassDevice - Medical Device Industry News
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