Class I Recall Issued for Stryker Pleural and Pneumopericardial Drainage SetsJan 13, 2016
The U.S. Food and Drug Administration (FDA) has placed its most serious recall status on a recall of pleural and pneumopericardial drainage sets manufactured by Stryker Fuhrman. According to the recall notice, the catheter included with the Fuhrman Pleural/Pneumopericardial Drainage Set can break off when inserted, leading to serious injury or death. Two cases have been reported with this issue so far, and both patients needed medical intervention.
"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." the recall notice states. The Fuhrman Pleural/Pneumopericardial Drainage Set is used to remove air from the sac around the heart, called the pericardium, and the pleural cavity covering the lungs. It can also drain fluid from the pleural cavity.
Class I recalls indicate that exposure to the recalled device can present a reasonable risk of serious injury or death. Stryker notified customers about the issue in a November 17, 2015 letter. Customers were instructed to stop using the product and to complete the Recall Effectiveness Check Form, regardless of whether the product is in inventory.