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The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. The devices described in this recall are related to the ongoing evaluation announced in the Potential Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis Machines Manufactured by Fresenius Medical Care – Letter to Health Care Providers. Please be aware, this recall is a correction, not a product removal. Reason for Recall Fresenius Medical Care is recalling some of its 2008 Series Hemodialysis Machines because patients may be exposed to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) that leach from some peroxide cured silicone tubing used as part of the hydraulics in the machine and dialysate lines. Data provided by the manufacturer indicates that the amount of NDL PCBAs decreases over the first month during routine clinical use of the hemodialysis machine. Fresenius Medical Care is updating affected machines manufactured between August 21, 2008 and June 6, 2022 that contain chlorinated peroxide cured silicone tubing and may not have been used or may have been in use for less than 36 days (or 486 total hours). The use of affected machines may cause serious adverse health consequences months to years after exposure, including endocrine dysfunction, liver issues, neurobehavioral changes, skin problems (acne, rashes), and male infertility. There have been no reports of death. |
