FDA Issues Class I Recall of Certain Fresenius Hemodialysis Machines

Credit: US Food and Drug Administration

The US Food and Drug Administration has announced a Class I recall of some hemodialysis machines from Fresenius Medical Care for potential exposure to toxic compounds.

The recall comes after the FDA announced it would be evaluating hemodialysis machines from Fresenius Medical Care for potential risk of exposure to toxic compounds in May 2022 and includes 8 specific models of 2008 Series Hemodialysis Machines. In their announcement, the FDA underlined the Class I recall was considered a correction and not a product removal.¹

According to the FDA, the distribution dates of the affected machines range from August 21, 2008 to June 6, 2022. The total number of recalled devices in the US is 207 and the recall was initiated on November 25, 2022.¹

On September 6, 2023, Fresenius Medical Care sent an Urgent Medical Device Correction letter to affected customers. This letter instructed customers to contact the company if they had a hemodialysis machine containing chlorinated peroxide cured silicone tubing and may not have been used or may have been in use for less than 36 days. The specific concern is related to potential for exposure to non-dioxin-like polychlorinated biphenyl acids from the tubing. For those with a new machine purchased after October 2022, no action is warranted. For those who require an update to their machine, Fresenius Medical is providing updates free of charge.^1,2

The FDA highlighted the following product codes and model numbers as part of the recall:¹

• 2008T HD SYS. W/O CDX BLUESTAR
• 2008T HD SYS. CDX W/BIBAG BLUESTAR
• 2008T HD SYS. CDX BLUESTAR
• 2008T HD SYS. W/O CDX W/ BIBAG BLUESTAR
• 2008T Hemodialysis SYS, with CDX
• 2008T Hemodialysis System without CDX
• 2008T Hemodialysis System w/Bibag
• 2008T GEN 2 Bibag without CDX

According to the FDA, those using affected machines could be at increased risk of serious adverse health consequences months to years after exposure. At the time of writing, there were no reports of death as a result of the potential exposure.¹

References:

1. Center for Devices and Radiological Health. Some hemodialysis machines for potential exposure to toxic compounds. U.S. Food and Drug Administration. Accessed October 24, 2023. https://www.fda.gov/medical-devices/medical-device-recalls/fresenius-medical-care-recalls-some-hemodialysis-machines-potential-exposure-toxic-compounds.
2. Center for Devices and Radiological Health. Potential Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis Machines Manufactured by Fresenius Medical Care – Letter to Health Care Providers. U.S. Food and Drug Administration. Accessed October 24, 2023. https://www.fda.gov/medical-devices/letters-health-care-providers/potential-risk-exposure-toxic-compounds-when-using-certain-hemodialysis-machines-manufactured.