The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Device Use

The Fresenius Medical Care Sanxin Single Use Sterile Syringes are used during hemodialysis treatments. They are used to draw heparin, a blood thinning medicine used to prevent blood clots. The heparin 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.

Reason for Recall

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. The use of affected syringes may cause serious, adverse health consequences, including blood stream infection (sepsis), or blood loss due to leakage. Other risks include the wrong heparin dosage, leading to blood clotting, embolism, and death. There have been 37 reported incidents and no reported injuries or deaths.