FDA Deems Recalls From Olympus and Fresenius as Class I

Fresenius Medical Care has recalled some of its hemodialysis machines for the potential of exposing patients to a harmful chemical, and Olympus has recalled an insufflation unit — and the FDA has deemed both these recalls as class I, the most serious type of recall because of the potential for serious side effects including death.

The Fresenius recall, initiated by the firm for 207 devices on Nov. 25, 2022 with a letter to customers, affects certain of its 2008 series hemodialysis machines. The concern is that 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.

Olympus’s recall concerns its High Flow Insufflation Unit, Mode UHI-4, used for laparoscopic surgery. The FDA said that there have been “reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used,” possibly because of “an over insufflation of the abdominal cavity” during the procedures.

The company initiated the recall with a Sept. 22 letter to customers of the 3,136 affected devices providing a field corrective action letter to users and directing customers to “ensure all personnel are completely knowledgeable and thoroughly trained on the content of this letter.”

Read the FDA notice on the Fresenius recall here.

Read the FDA notice on the Olympus recall here.

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