FDA recalls syringe used by dialysis patients, classified as serious

Mass. — The FDA is warning dialysis patients about a recent syringe recall that could kill them.

Waltham’s Fresenius Medical Care is recalling its Sanxin Single Use Sterile Syringes due to blood or heparin leaking back or from the syringe. There have also been reports of an unknown black material inside the syringe.

This recall is classified as a Class I recall, which means the FDA believes using these products “may cause serious injuries or death.”

The following Syringes are included in the recall:

The recall includes 12,477,300 Sanxin Single Use Sterile Syringes (124,773 boxes of 100 syringes each) distributed from April 2021 to August 2023.

“The use of affected syringes may cause serious adverse health consequences, including bloodstream infection (sepsis), or blood loss due to leakage. Other risks include the wrong heparin dosage, leading to blood clotting, embolism, and death,” the FDA says.

There have been 37 reported incidents and no reported injuries or deaths.

For more information on the recall, click here.

This is a developing story. Check back for updates as more information becomes available.

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