Stryker Sustainability Solutions has initiated a recall of the Fuhrman Pleural/Pneumopericardial Drainage Set, after two reports that the catheter included in the drainage set broke off in the pleural cavity. This is a Class 1 recall, the FDA’s most serious recall category, reserved for situations where the patient may suffer serious injury or death.
The Food and Drug Administration (FDA) says that both cases where the catheter broke off required medical intervention.
The Fuhrman Pleural/Pneumopericardial Drainage Set is used to remove air from the sac (pericardium) surrounding the heart, or to drain air or fluid from the thin covering (pleural cavity) that protects the lungs.
The recalled drainage set is item number G03974; a list of the lot numbers can be found on the FDA web site. The recalled drainage sets were manufactured from November 6, 2009 to October 21, 2011 and were distributed December 12, 2009 to October 28, 2011. The drainage sets were distributed in Alaska, California, Florida, Indiana, New York, North Carolina, Oregon, and Wisconsin.
Stryker sent recall notification letters to customers on November 17, 2015. The letter advised customers to discontinue use of the recalled Fuhrman Pleural/Pneumopericardial Drainage Sets. Customers who have the affected drainage sets in their inventory will be given a prepaid shipping label to return the drainage set(s) to Stryker. The firm said customers will receive credit for all affected drainage sets returned.