Stryker Drainage Set Catheter Recall News
Due to a serious and possibly lethal device flaw, Stryker Sustainability Solutions’ “Fuhrman Pleural/Pneumopericardial Drainage Set” was subject to a Class I Recall. The Stryker Drainage Set, which 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,” includes a catheter that is snaked into the patient’s chest.
The Stryker Drainage Set Catheter recall was initiated after two reports of this catheter having broken off in the pleural cavity while inserting the device into the patient. Both cases were severe and warranted medical intervention.
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Stryker Drainage Set Catheter Recall Information
The affected Fuhrman Pleural & Pneumopericardial Drainage Sets were manufactured between November 6, 2009 and October 21, 2011, and distributed between December 12, 2009 and October 28, 2011.
In the U.S., 34 devices have been recalled in the following states:
Alaska (AK), California (CA), Wisconsin (WI), Indiana (IN), Florida (FL), Oregon (OR), New York (NY), and North Carolina (NC).
The recall extends to devices with the Item Number G03974 and the following lot numbers:
Image of the Fuhrman Pleural & Pneumopericardial Drainage Set
• 295397U
• 331621U
• 374044U
• 394431U
• 406125U
• 406131U
• 410982U
• 412655U
• 415094U
• 422060U
• 519812U
• 7718289U
• 838193U
