Dive Brief:
- Fresenius Medical Care has recalled millions of devices used to connect dialysis catheters and systems after finding a chemical can leak from the tubing. The company will correct its instructions for the devices, warning that patients who weigh under 40 kilograms (about 88 pounds) could be exposed to more than allowable levels of a toxic compound with use of the products.
- The Class I recall covers almost 2.2 million extension sets and adapters, according to a Thursday recall notice posted by the Food and Drug Administration. The devices have silicone tubes that can expose patients to non-dioxin-like (NDL) polychlorinated biphenyl acid (PCBA). The agency noted that the recall does not require product removal.
- The FDA shared news of the action, which is the latest in a series of steps to mitigate the risks of NDL-PCBAs, alongside details of Outset Medical’s recall of its Tablo hemodialysis system.
Dive Insight:
The FDA wrote to healthcare providers in 2022 to warn about the potential for some Fresenius Medical Care hemodialysis systems to expose patients to NDL-PCBAs and NDL polychlorinated biphenyls (PCBs). Fresenius Medical Care made its silicone tubes using a chlorinated peroxide initiator that potentially risks exposure to NDL-PCBAs and NDL-PCBs.
“Although this silicone tubing does not directly contact the blood, there is the potential for back filtering through the dialyzer into the patient’s blood circulation during treatment,” the agency wrote in the letter.
In response, Fresenius Medical Care switched to platinum catalyst silicone tubing and recalled devices made using the old process. However, the company later identified the potential for Stay-Safe Catheter Extension Sets and Stay -Safe/Luer Lock Adapters to leach NDL-PCBAs, leading to the latest recall.
In the Thursday notice, the FDA said exposure to NDL-PCBs or NDL-PCB-related compounds could cause health problems such as liver issues, neurobehavioral changes and other conditions.
Fresenius Medical Care began recalling almost 2.2 million devices in January because patients who weigh less than 40kg may be exposed to unacceptable levels of NDL-PCBAs.
Fresenius Medical Care distributed the devices in the U.S. between 2003 and 2024 and has received no reports of injuries or deaths.
The company has written to healthcare professionals to advise them to use the shortest length extension set when treating patients who weigh less than 40kg and to avoid using the adapter if possible. The letter explained the NDL-PCBA exposure levels based on body weight, treatment length and various device combinations.
The FDA shared details of Fresenius Medical Care’s actions alongside news of a recall by Outset Medical, another manufacturer of dialysis systems. Outset Medical has recalled 879 Tablo hemodialysis devices because the tubing may leach unacceptable levels of NDL-PCBAs for the first 336 hours of use.
The recall aims to change the tubing for machines that have run for less than 336 hours, and the company advised users of machines run for less than that time to consider using other devices until their systems are serviced.