The FDA issued a safety watch and recall for the Pleural and Pneumopericardial Drainage Sets by Stryker Fuhrman because the the catheter included in the Drainage Set has broken off in the lung while inserting the device into the patient. The devices are used in emergency medicine, pulmonology and cardiology
The recall involves the Fuhrman Pleural and Pneumopericardial Drainage Set, which is used to drain air or fluid from the pericardium (sac around the heart) or the pleural cavity (thin covering that protects the lungs) while inserting the device into the patient.
Stryker Sustainability Solutions received two reports that the catheter broke off in the pleural cavity. Both cases resulted in the need for medical intervention. This issue could cause serious patient injury or death.
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 firstname.lastname@example.org 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: (888) 888-3433 x5555.