On November 15, 2023, the U.S. Food and Drug Administration (FDA) reported that Fresenius Medical Care is recalling three types of its Sanxin single-use syringes because of leakages. FDA identified it as a class I recall, the most serious type of recall, where use of the devices may cause serious injuries or death.
Fresenius Medical Care Sanxin single-use sterile syringes are used to draw heparin during hemodialysis treatments, which is then mixed with the blood in the hemodialysis machine using a mechanical syringe pump. The syringes are connected to the Fresenius 2008T hemodialysis machine and pressurized for the duration of the hemodialysis treatment.
The manufacturer is recalling the syringes because of reports of blood or heparin leaking back or from the syringe and reports of an unknown black material inside the syringe. Use of the affected syringes may cause serious adverse health events, including blood stream infection (sepsis); blood loss; and incorrect heparin dosage, leading to blood clotting, embolism, and death. As of November 15, FDA is aware of 37 reported incidents and no reported injuries or deaths.
The recall affects 12,477,300 units (124,773 boxes of 100 syringes each) of Sanxin single-use sterile syringes distributed in the United States from April 30, 2021–August 7, 2023. The following product codes and part numbers are recalled:
- 10 ml syringe, Luer lock with needle, part number 15-10ml-0
- 10 ml syringe, Luer lock without needle, part number 15-r010-0
- 3 ml syringe, Luer lock with needle 20gx1, part number 15-03ml-0
On August 8, 2023, Fresenius Medical Care sent all affected customers an urgent product recall letter that instructed them to:
- Check your stock. If you have any of the recalled syringes, place the product in a secure segregated area.
- Contact Fresenius Medical Care Renal Therapies Group at 800-323-5188 for instructions on how to return the product and receive credit.
- Reference FA-2023-17-C RECALL.
- Specify whether you need an urgent product replacement.
U.S. customers with questions about the recall should contact Fresenius Medical Care Renal Therapies Group Customer Service at 800-323-5188.
Healthcare professionals and consumers should report adverse reactions or quality problems they experienced using the devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.