FDA alerts to Class I recall of Stay-Safe Catheter Extension Sets, Stay-Safe/Luer Lock Adapter due to potentially unsafe levels of NDL-PCBA

The FDA is warning consumers that Fresenius Medical Care has recalled its Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapter because use of the products were found to put patients at risk of exposure to high levels of the toxic compound NDL-PCBA.

Initiated by the company on January 23, 2024, the corrective recall has since been labeled Class I, the most serious type, because exposure to the above-normal levels of the compound could lead to major injuries or death.

Officials say 2,192,535 devices that were distributed across the U.S. between March 5, 2003 and January 25, 2024 are covered by the recall. The following product codes of Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapter are affected:

The devices are designed to be used by patients receiving peritoneal dialysis in both healthcare and home settings for the treatment of acute and chronic end-stage kidney, or renal, disease. The Stay-Safe Catheter Extension Sets and the Stay-Safe/Luer Lock Adapters work to “connect peritoneal dialysis catheters to peritoneal dialysis systems.”

Fresenius Medical Care first took action after being alerted to the presence of non-dioxin-like (NDL) polychlorinated biphenyl acid (PCBA) in the devices’ “peroxide-cross linked” silicone tubing. Officials say the defect makes it possible for a patient’s peritoneal cavity to become exposed to above-allowable levels of NDL-PCBA compounds through a dialysate solution. Those who weigh less than 40 kilograms were determined to be at particular risk of overexposure.

Major health consequences that may arise out of exposure to NDL-PCBs or other NDL-PCB compounds over months and years are as follows: “endocrine dysfunction, liver issues, neurobehavioral changes, skin problems (acne, rashes), and male infertility.”

While the company has not received any reports of injuries or deaths in connection to the problem to date, patients weighing less than 40 kg and who are likely to receive peritoneal dialysis through the extension sets and adapters may be affected by the recall. Healthcare providers who use the devices to administer peritoneal dialysis to patients fitting the risk profile should also be advised.

Customers began receiving Important Medical Device Correction Letters from Fresenius Medical Care on February 14, 2024, which alerted them to the possibility of NDL-PCBAs leaching out from the devices. The communication, which outlined NDL-PCBA exposure threshold examples correlative to body weights both less than 10kg and up until 40kg, as well as length of treatment and multiple device combinations, indicated that those weighing more than 40kg are not at risk. Healthcare providers were advised of the following:

  • Dialysis treatments should continue to be carried out for all patients, even for those weighing less than 40 kg.
  • When treating those with a body weight less than 40 kg, including infants and neonates, only the shortest length extension set (“6-inch, Part No. 050-95013”) should be used, and the adapter should not be used.
  • Be aware that the information applies to both current patients and those on the verge of starting peritoneal dialysis.
  • Be up-to-date on recommendations from both Fresenius Medical and the FDA.

Those with further questions are asked to contact the Global Medical Information and Education Office at Fresenius Medical by calling 855-616-2309.

As the FDA continues to monitor this recall, healthcare professionals and consumers alike are urged to report adverse experiences and quality issues to the agency’s MedWatch program.


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