Stryker Announces Medical Device Recall Due to Fragile Catheter
A catheter that is prone to breaking is now subject to a recall.
Stryker Sustainability Solutions, in cooperation with the Food and Drug Administration (FDA) is voluntarily recalling the Fuhrman Pleural & Pneumopericardial Drainage Set. In two instances, the catheter included in these sets has broken 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 recalled sets bear item number G03974. The manufacturer believes that about 35 of these items is defective.
The product was distributed to medical doctors in Alaska, California, Florida, Indiana, New York, North Carolina, Oregon, and Wisconsin.
Consumers in possession of the recalled product should immediately discontinue use and return to the device to Stryker. Customers will receive credit for all affected devices returned.
Individuals with questions about this recall can contact the Stryker Sustainability Solutions Complaint Hotline at (888) 888-3433, extension 5555.