The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death
- Fuhrman Pleural & Pneumopericardial Drainage Set
- Item Number G03974 and Lot Numbers
- Manufacturing dates: November 6, 2009 to October 21, 2011
- Distribution Dates: December 12, 2009 to October 28, 2011 in multiple states
- Devices Recalled in the U.S.: 34
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 thin covering (pleural cavity) that protects the lungs.
The primary users of this device are medical doctors.
Image of the Fuhrman Pleural & Pneumopericardial Drainage Set
Reason for Recall
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.
Who may be affected
- Health care providers using the Fuhrman Pleural & Pneumopericardial Drainage Set
What to Do
Stryker sent customer notification letters on November 17, 2015. The letter indicated that customers should:
- Discontinue use of the product
- Complete the Recall Effectiveness Check Form even if no product has been found in inventory
- Return the form to their local Stryker Sustainability Sales Representative via email at email@example.com or mail to: Stryker Sustainability Solutions, 1810 West Drake Drive Tempe, AZ 85283 Attn: Jodie Rueckert
- If the firm indicates that affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product.
- Customers will receive credit for all affected devices returned.
Customers with questions should contact the Stryker Sustainability Solutions Complaint Hotline: 1(888) 888-3433 x5555.
Date Recall Initiated
November 17, 2015
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX
- Alaska (AK)
- California (CA)
- Wisconsin (WI)
- Indiana (IN)
- Florida (FL)
- Oregon (OR)
- New York (NY)
- North Carolina (NC)