FDA Reports Fresenius Medical Care’s Recall of Sanxin Single-Use Syringes

November 15, 2023

On November 15, 2023, the U.S. Food and Drug Administration (FDA) reported (https://www.fda.gov/medical-devices/medical-device-recalls/fresenius-medical-care-recalls-sanxin-single-use-syringes-leakages) 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.

FDA update

Fresenius Medical Care Sanxin single-use sterile syringes are used to draw heparin during hemodialysis (https://medlineplus.gov/ency/patientinstructions/000707.htm) 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 (https://medlineplus.gov/pulmonaryembolism.html), 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:

On August 8, 2023, Fresenius Medical Care sent all affected customers an urgent product recall letter that instructed them to:

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 (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) they experienced using the devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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