FDA: Class I recall of Stryker Pleural and Pneumopericardial Drainage Sets

Editor's Note

The Food and Drug Administration (FDA) on January 11 classified the recall of Stryker Fuhrman’s Pleural and Pneumopericardial Drainage Sets as Class I, the most serious.

Stryker (Tempe, Arizona) received two reports that the catheter included in the Drainage Set broke off in the patient’s pleural cavity during insertion. This issue may cause serious injury or death.

Posted 01/11/2016] AUDIENCE: Emergency Medicine, Pulmonology, Cardiology ISSUE: 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.