The FDA says a recall of Fresenius Medical Care catheter extension sets and luer lock adapters is Class I, the most serious kind.
Fresenius Medical Care initiated the recall of a number of its Stay-Safe luer lock adapters and catheter extensions on Jan. 23, 2024. It extends to nearly 2.2 million devices distributed between March 5, 2003, and Jan. 25, 2024. To date, the company reports no injuries or deaths related to the recall.
The sets and adapters connect peritoneal dialysis catheters to peritoneal dialysis systems. They are indicated for patients with acute and chronic end-stage kidney (renal) disease. These patients undergo peritoneal dialysis at health care facilities or in home settings.
Fresenius Medical Care issued the recall to correct the instructions for use. The company found non-dioxin-like (NDL) polychlorinated biphenyl acid (PCBA) leaching in the peroxide-cross linked silicone tubing. These compounds can enter a patient’s peritoneal cavity via the dialysate solution.
Patients who weigh less than 40 kg (roughly 88.2 pounds) may be exposed to more than allowable levels of the compounds as a result. Exposure may cause serious adverse health consequences months to years after exposure. The FDA notice lists endocrine dysfunction, liver issues, neurobehavioral changes, skin problems (acne, rashes), and male infertility as potential consequences.
According to Fresenius Medical Care, the recall does not affect patients who weigh more than 40 kg. Providers may continue to provide dialysis treatments to all patients, including those who weigh less than 40 kg. However, when treating patients under 40 kg, they should only use the shortest length extension set (6-inch).
