The FDA has issued a Class I recall for Stryker Fuhrman’s Pleural and Pneumopericardial Drainage Sets. Notification letters were sent to customers by Stryker on Nov 17, 2015, urging them to discontinue use of the product immediately.
The Fuhrman Pleural/Pneumocardial Drainage set is used primarily by medical doctors to remove air from the pericardium (the sac surrounding the heart), or drain fluid from the pleural cavity (the thin covering protecting the lungs.) It was distributed between December 12, 2009 and October 28, 2011 to the following U.S. states:
- Alaska (AK)
- California (CA)
- Wisconsin (WI)
- Indiana (IN)
- Florida (FL)
- Oregon (OR)
- New York (NY)
- North Carolina (NC)
Stryker Sustainability solutions had received two reports detailing that the catheter in the drainage set broke off in the pleural cavity during insertion into the patient. Medical intervention was necessary in both instances. Healthcare providers using the product are encouraged to stop using it immediately, as the broken catheter can result in serious patient injury or death.
Customers should complete the Recall Effectiveness Check Form and return it to Stryker Sustainability Solutions via e-mail to a sales representative (email@example.com) or mail to Stryker Sustainability Solutions, 1810 West Drake Drive Tempe, AZ 85283 Attn: Jodie Rueckert.
Customers will receive credit upon return of affected devices.