FDA Recalls Chest Drainage Catheter Because It Can Break

FDA Recalls Chest Drainage Catheter Because It Can BreakJanuary 11, 2016 — The FDA has issued a Class 1 recall for a chest drainage catheter that can break inside a patient when it is being inserted.

The Fuhrman Pleural and Pneumopericardial Drainage Set is used to remove air from the pericardium, which is a sac surrounding the heart. It may also be used to drain air or fluid from the pleural cavity, which is a thin sac around the lungs.

The product was manufactured by Stryker Sustainability Solutions. The company has received two reports of the catheter breaking off inside the pleural cavity while the device was being inserted into a patient. According to the FDA:

“Both cases resulted in the need for medical intervention. This issue could cause serious patient injury or death.”

Stryker notified customers of the problem in letters sent on November 17, 2015. The letter asked customers to stop using the product, look through their inventory, and return any products that were discovered.

The recall involves 34 catheters that were sold as part of a set with Item Number G03974. They were sold between December 2009 and October 2011. Click here for a complete list of recalled lot numbers.

Class I recalls are the most serious type of recall, only issued when the FDA determines that the use of a device may cause serious injuries or death.

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