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Chest Drainage Kit Recalled Because Catheter Can Break

Chest Drainage Kit Recalled Because Catheter Can Break

January 11, 2016 — Stryker has issued a recall for a chest drainage kit because a catheter included in the kit may break when it is being inserted into a patient.

The recall involves the Fuhrman Pleural and Pneumopericardial Drainage Set, which is used to drain air or fluid from the pericardium (sac around the heart) or the pleural cavity (thin covering that protects the lungs).

According to the FDA:

“Stryker Sustainability Solutions received two reports that the catheter included in the Drainage Set broke off in the pleural cavity while inserting the device into the patient. Both cases resulted in the need for medical intervention. This issue could cause serious patient injury or death.”

The FDA issued a Class 1 recall, which is the most serious type of recall. It is only issued when the FDA believes use of a device has a reasonable probability of causing severe injury or death.

The recall began when Stryker notified customers by letter on November 17, 2015. The recall involves 34 catheters that were sold as part of a kit from December 2009 through October 2011 in the United States. The item number is G03974. Click here for a complete list of recalled lot numbers.

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