FDA announces recall of more than 2 million catheter parts, citing serious health risks
Fresenius Medical Care is issuing a recall on several catheter extensions and adapters used in patients with acute and chronic kidney disease. Due to the risk of “serious adverse health consequences,” the U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type.
What is being recalled?
The products being recalled are from the Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapter lines, commonly used in home care environments to connect catheters to peritoneal dialysis systems. The affected 2,192,535 devices were distributed from March 5, 2003 to January 25, 2024.
The following devices are being recalled. Specific product codes can be found by clicking the links:
Why is this necessary?
According to the FDA notice, non-dioxin-like (NDL) polychlorinated biphenyl acid (PCBA) leaching was found in the silicone tubing of the adapters and extensions. As a result, patients who weigh less than 40 kg (88.2 lbs) may be exposed to “more-than-allowable” levels of NDL-PCBAs, compounds known to cause liver issues, neurobehavioral changes, rashes and infertility in men.
Fortunately, Fresenius Medical has reported no injuries or deaths linked to the recalled parts. The company first issued a warning to customers and providers in February, with updated instructions on how to avoid NDL-PCBAs contamination.
Next steps
If a patient weights more than 40 kg (88.2 lbs), there is no need to do anything. For those under the weight limit, clinicians should cease use of these products immediately.
However, the FDA recommends dialysis treatment be continued for all patients. For those under 40 kg, the FDA is advising providers to use the shortest catheter extension possible (6-inch, Part No. 050-95013) and to avoid using the adapter. This should sufficiently reduce exposure to NDL-PCBAs.
The full FDA recall notice can be found here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.