Fresenius Medical Care Recalls Stay-Safe Catheter Extension Sets and Stay-Safe Adapter

Urgent Class I Recall Notice  

FDA has issued a Class I recall – the most serious type – for certain medical devices manufactured by Fresenius Medical Care. The recall concerns Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapters, pivotal components used in peritoneal dialysis treatments for patients with acute and chronic end-stage kidney disease. 

Recalled Product Details

• Product Name: Stay-Safe Catheter Extension Sets, Stay-Safe/Luer Lock Adapter 
• Product Codes: [See Recall Database Entries for detailed codes] 
• Devices Recalled in the U.S.: 2,192,535 
• Dates Distributed: March 5, 2003 to January 25, 2024 
• Date Initiated by Firm: January 23, 2024 

Reason for Recall 

Fresenius Medical Care is conducting this recall to rectify instructions for using the Stay-Safe Catheter Extension Sets and Adapters. Recent findings revealed the presence of non-dioxin-like (NDL) polychlorinated biphenyl acid (PCBA) leaching in the peroxide-cross linked silicone tubing of these devices. This substance has the potential to enter a patient’s peritoneal cavity during dialysis, particularly affecting patients weighing less than 40 kg. 

Potential Risks

Exposure to NDL-PCBAs can lead to severe health consequences, including but not limited to endocrine dysfunction, liver issues, neurobehavioral changes, skin problems, and male infertility. Although no injuries or deaths have been reported thus far, the gravity of these risks cannot be understated. 

Who May Be Affected

• Patients with body weight less than 40 kg (88 lbs.) undergoing peritoneal dialysis with the mentioned devices 
• Health care providers utilizing Stay-Safe Extension Sets or Stay-Safe/Luer Lock Adapters during peritoneal dialysis for patients weighing less than 40 kg 

Recommended Actions

In response to this recall, Fresenius Medical Care has initiated an Important Medical Device Correction, which includes the following recommendations: 

• Continue dialysis treatments for all patients, including those with body weight less than 40 kg. 
• Use only the shortest length extension set (6-inch) when treating patients weighing less than 40 kg and, if possible, avoid using the adapter. 
• Stay vigilant for further updates and recommendations from Fresenius Medical and the FDA. 

Contact Information

For any inquiries or concerns, customers can reach out to Fresenius Medical’s Global Medical Information and Education Office at 855-616-2309. 

Report Adverse Reactions

Healthcare professionals and consumers are encouraged to report any adverse reactions or quality problems related to these devices through MedWatch: The FDA Safety Information and Adverse Event Reporting Program. 

Conclusion

While this recall is a correction rather than a product removal, it underscores the critical importance of maintaining patient safety in medical device usage. Patients and healthcare providers must remain vigilant in monitoring and reporting any adverse events. Effective communication and swift action are paramount in mitigating potential risks and ensuring the well-being of patients undergoing peritoneal dialysis treatments. 

Links 

Read the FDA recall announcement here.