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.
Recalled Product
Device Use
Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapter are indicated for use in patients with acute and chronic end-stage kidney (renal) disease who are undergoing peritoneal dialysis at health care facilities or in home settings.
The extension sets and adapters are used to connect peritoneal dialysis catheters to peritoneal dialysis systems.
Reason for Recall
Fresenius Medical Care is issuing a recall to correct the instructions for use of the Stay-Safe Catheter Extension Sets and Stay -Safe/Luer Lock Adapters after non-dioxin-like (NDL) polychlorinated biphenyl acid (PCBA) leaching was found in the peroxide-cross linked silicone tubing for these devices. These NDL-PCBA compounds can enter a patient’s peritoneal cavity via the dialysate solution.
Patients who are less than 40 kg may be exposed to more than allowable levels of NDL-PCBAs as a result of this issue. NDL-PCBAs are an acid of NDL-PCBs. Exposure to NDL-PCBs or NDL-PCB related compounds 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.
Fresenius Medical Care reports no injuries or deaths related to this issue.
Who May Be Affected
- Patients with body weight less than 40 kg, who may receive peritoneal dialysis with Stay-Safe Extension Sets or Stay-Safe/Luer Lock Adapter
- Health care providers who use Stay-Safe Extension Sets or Stay-Safe/Luer Lock Adapter during peritoneal dialysis for patients with body weight less than 40 kg.
What to Do
On February 14, 2024, Fresenius Medical Care began issuing an Important Medical Device Correction letter informing customers that NDL-PCBAs could leach from the extension sets and adapters. The letter provided NDL-PCBA exposure threshold examples per body weight (less than 10kg and between 10 and 40 kg), treatment length and various device combinations, and noted that patients with body weight greater than 40kg are not impacted. The following actions are recommended for health care providers:
- Continue to provide dialysis treatments to all patients including those with body weight less than 40 kg.
- Use only the shortest length extension set (6-inch, Part No. 050-95013) when treating patients with a body weight below 40 kg, including infants and neonates and if possible, avoid using the adapter.
- This is for both existing patients and patients about to initiate peritoneal dialysis.
- Remain alert for further updates and recommendations from Fresenius Medical and the FDA.
Contact Information
Customers with questions should contact Fresenius Medical’s Global Medical Information and Education Office at 855-616-2309.
Additional Resources
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.
