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…