Fresenius Sanxin Single Use Syringe Recall Issued Due to Risk of Blood, Heparin Leaks

Federal safety regulators have announced a Class I recall for more than 12 million Sanxin Single Use Syringes, after determining that the devices are defective and may leak blood or heparin from the syringe, potentially increasing the risk of infections and life-threatening injuries.

The U.S. Food and Drug Administration (FDA) announced the Fresenius syringe recall on August 8, after receiving at least thirty seven reports of the single-use syringes leaking during use, as well as indications that some of the devices contained an unknown black substance.

The recalled syringes are commonly used in conjunction with Fresenius 2008T hemodialysis machines to treat those with end stage kidney failure. Officials indiciate that individuals requiring dialysis treatment may be at a particularly high risk of serious injuries from the leaking syringes, including a potential risk of death.

Among the adverse events received, some doctors have described an unidentified black substance in the syringes and leaks from both ends, which can increase the risk of  severe health issues including bloodstream infections, sepsis, significant blood loss, incorrect heparin dosages, increased blood clotting risk, embolism, and potentially fatal outcomes.

Heparin is a drug often given to patients, especially critically ill patients, to prevent blood clots. However, in some rare cases it can induce severe bleeding, or heparin induced thrombocytopenia.

Sanxin Single Use Syringes Recall

The recall includes certain lots of the Sanxin Single Use Sterile Syringes manufactured by Fresenius Medical Care. The affected devices include, 10ML Syringe Luer Lock W/Out Needle 15-R010-0, 10ML Syringe Luer Lock W/Needle 15-10ML-0, 3ML Syringe Luer Lock with needle 20GXI 15-03ML-0.

The recalled single use syringes were distributed across the U.S. from April 30, 2021 through August 7, 2023. The FDA is urging distributors and healthcare providers to pull the infected brands from their inventory immediately, and place the product in a secure, segregated area.

Individuals using the recalled syringes are encouraged to report adverse reactions or quality problems to the FDA’s MedWatch  Safety Information and Adverse Event Reporting Program where you can email, mail or fax your online form. Consumers with questions can contact Fresenius Medical Care Renal Therapies Group Customer Service at 1-800-323-5188.