Fresenius Medical Care, Outset Medical issue recalls over leaking tubing sets
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Key takeaways
- The recalls are related to FDA concerns about a toxic compound leaching from tubing used on dialysis machines.
- The recalls are class I, meaning these could lead to serious injuries or patient deaths.
Fresenius Medical Care and Outset Medical Inc. have launched separate recalls over concerns that tubing in the dialysis machines they manufacture may be leaching a toxic compound during treatment, according to an FDA notice.
The FDA has classified both recalls as class I, meaning serious injuries or patient deaths could occur.
The Fresenius Medical Care recall, which has been ongoing since April, involves use of peroxide cross-linked silicone tubing in more than 2 million Stay-Safe catheter extension sets and Stay-Safe/Luer Lock adapters used in peritoneal dialysis machines to treat pediatric patients.
The tubing sets were distributed from March 5, 2003, to Jan. 25, 2024, according to the FDA.
The recall by Outset Medical of its Tablo Hemodialysis Systems involves leaching of the toxic compound from peroxide-cured silicone tubing used as part of the machine’s hydraulics and for dialysate lines. Outset told customers in an important medical device correction letter sent in March to use other dialysis machines if possible until the tubing can be replaced, according to the FDA.
The company has recalled 879 Tablo machines distributed from Aug. 25, 2018, to Dec. 4, 2023. Tablo machines with a serial number starting at 604572M were manufactured with platinum-cured tubing and are not affected, according to the FDA.
The recalls are part of an investigation launched in April 2023 by the FDA about the risk of non-dioxin-like polychlorinated biphenyl acids (NDL-PCBAs) for patients undergoing dialysis. NDL-PCBAs are an acid of NDL-PCBs; exposure to NDL-PCBs or NDL-PCB-related compounds may cause serious adverse health consequences months to years after exposure, including endocrine dysfunction, liver issues, neurobehavioral changes, skin problems (such as acne or rashes) and male infertility, according to the FDA.
In November 2023, Fresenius Medical Care agreed to recall some of its 2008 Series hemodialysis machines to replace tubing that was leaching NDL-PCBAs. In April, Fresenius Medical Care’s Fresenius Medical Care Renal Therapies Group (FMCRTG) sent an important medical device correction letter informing customers about the recall.
“FMCRTG has determined through testing that non-dioxin-like polychlorinated biphenyl acids (PCBAs) could leach from the Stay Safe Catheter Extension sets and adapter, which are manufactured using peroxide cross-linked silicone tubing,” according to the letter. “ ... PCBA levels decrease with shorter catheter extension sets and decrease over the treatment time. Therefore, FMCRTG recommends use of the shortest catheter extension set length (6-inch) with patients [weighing less than] 40 kg.”
In a statement to Healio, Fresenius Medical Care said, “While medical literature has not identified any health effects related to PCBA exposure, PCBA levels above toxicological relevant thresholds may be of concern. Fresenius Medical Care has not received any reports of adverse events related to the catheter extension sets and Luer Lock adapter, and we are not aware of FDA receiving any such reports. We are working to manufacture and provide catheter extension sets with silicone tubing that has been shown not to leach PCBAs.”
The FDA noted that the NDL-PCBAs can enter a patient’s peritoneal cavity via the dialysate.
References:
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 | FDA. https://www.fda.gov/medical-devices/medical-device-recalls/fresenius-medical-care-recalls-stay-safe-catheter-extension-sets-and-stay-safeluer-lock-adapter-risk. Published April 25, 2024. Accessed May 1, 2024.
Outset Medical Inc. recalls certain Tablo Hemodialysis Systems for risk of patient exposure to higher than allowable levels of toxic compound NDL-PCBAs | FDA. https://www.fda.gov/medical-devices/medical-device-recalls/outset-medical-inc-recalls-certain-tablo-hemodialysis-systems-risk-patient-exposure-higher-allowable. Published April 25, 2024. Accessed May 1, 2024.
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