FDA Medical Device Recall
Fresenius Medical Care Recalls Sanxin Single Use Syringes for Leakages
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.
KCER Release Date: November 15, 2023
To: KCER Distribution list- including ESRD Network EDs and QIDs
- Product Names: Sanxin Single Use Sterile Syringes
- Product Codes and Part Numbers:
- Distribution Dates: April 30, 2021 to August 7, 2023
- Devices Recalled in the U.S.: 12,477,300 units (124,773 boxes of 100 syringes each)
- Date Initiated by Firm: August 5, 2023
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.
Who May be Affected
- People who are treated using Fresenius hemodialysis machines with Sanxin Single Use Sterile Syringes.
What to Do
On August 8, 2023, Fresenius Medical Care sent all affected customers an Urgent Product Recall letter.
The letter requested customers 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 for instructions on how to return the product and receive credit
- Reference FA-2023-17-C RECALL
- Specify if urgent replacement of product is needed when calling.
Customers in the U.S. with questions about this recall should contact Fresenius Medical Care Renal Therapies Group Customer Service at 1-800-323-5188.
Full List of Affected Devices
10ML SYRINGE LUER LOCK W/OUT NEEDLE
10ML SYRINGE LUER LOCK W/NEEDLE
3ML Syringe Luer Lock with needle 20GX1
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.