On January 4th, 2016 the U.S. Food and Drug Administration (FDA) identified a Class I recall designation (the most serious type of recall) for the Stryker Fuhrman Pleural & Pneumopericardial Drainage Set medical device. According the FDA, this device is used to remove air from the sac (pericardium) surrounding the heart, or to drain air or fluid from thin covering (pleural cavity) that protects the lungs. FDA Announcement
The recall was implemented after the company Stryker Sustainability Solutions received two reports that the catheter included in the Drainage set broke off during insertion into the patients’ pleural cavity. Both incidents required additional medical intervention. A Class I recall is only issued when the FDA believes use the products use could cause serious patient injury or death.
In its customer notification letter sent November 17, 2015 Stryker instructs customers to discontinue the use of the product. The recalled product (item number G0974) was distributed from December 12, 2009 till October 28, 2011 in the following states: Alaska, California, Wisconsin, Indiana, Florida, Oregon, New York, and North Carolina. A complete list of affected lot numbers can be found by clicking here for the FDA’s website.
If you or a loved one suffered injuries that you believe were caused by a Stryker Fuhrman Pleural & Pneumopericardial Drainage Set contact one of the experienced medical device attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today