Medline recalls procedure kits due to catheter safety concerns
Medline, the Illinois-based medical supplier, is recalling thousands of procedure kits used by cardiologists and cardiac surgeons due to the inclusion of Swan-Ganz catheters manufactured by Becton Dickinson (BD). The U.S. Food and Drug Administration (FDA) has ruled this as a Class II recall.
In May, BD recalled a large number of Swan-Ganz catheters due to a risk of the devices leaking or breaking in a way that could result in “infection, medication loss and/or blood loss.” The Class II recall impacted approximately 590,000 catheters distributed all over the United States in addition to other parts of the world.
Now, Medline is recalling more than 9,000 procedure kits that feature those same catheters. This includes procedure kits used by surgeons performing open-heart surgery, and cath lab kits used for right heart catheterization procedures.
Customers are not required to return any recalled devices. Instead, BD—with help from the FDA—has highlighted specific ways to mitigate the risk of leakage or breakage.
Recommendations include:
- Secure the catheter lumens to an IV arm board to minimize the possibility of bending/flexing
- Consider the use of a catheter stopcock
- Shift to “automated cardiac output models” to minimize stress on the device
- Utilize transthoracic or transesophageal echocardiography to help monitor central venous pressure via a central venous catheter when patients require right ventricle monitoring and management.
Click here for additional details from the FDA.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.