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Fresenius Medical Care Recalls Stay-Safe Catheter Extension Sets and Stay-Safe /Luer Lock Adapter for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA 

Fresenius Medical Care is recalling these devices to provide a correction to the instructions for use of the Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapter after non-dioxin-like (NDL) polychlorinated biphenyl acid (PCBA) leaching was found in the peroxide-cross linked silicone tubing for these devices. These NDL-PCBA compounds can enter a patient’s peritoneal cavity via the dialysate solution. Patients who are less than 40 kg may be exposed to higher than allowable levels of NDL-PCBAs as a result of this issue.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these affected devices, without following the updated instructions for use, may cause serious injuries, serious health consequences, or death. Please be aware, this recall is a correction, not a product removal. 

Questions?

Customers with questions should contact Fresenius Medical’s Global Medical Information and Education Office at 855-616-2309.