Two incidents of catheter breakage in the Fuhrman Pleural/Pnemopericardial Drainage Set (Stryker Sustainability Solutions; Tempe, AZ) have been reported.
The Drainage Set broke off in the pleural cavity while the device was being inserted into the patient and required medical intervention. Serious injury or death could result.
Stryker notified customers via letter in November 2015 indicating that users should discontinue product, complete the Recall Effectiveness Check Form even if no product is in their inventory, return forms to local Stryker Sustainability Sales Representation via email or mail, a prepaid shipping label will be issued for any returns, and credit will be issued for all affected devices returned.
For more information or to submit an online report, please visit the safety alert on the US Food and Drug Administration website.
Pleural and pneumopericardial drainage sets by Stryker Fuhrman – class I recall – catheter may break during insertion [news release]. Silver Spring, MD: US Food and Drug Administration; January 11, 2016. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm481251.htm. Access January 12, 2016.