FDA Issues Class I Recall on Fresenius Medical Care’s Sanxin Single Use Sterile Syringes

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FDA Issues Class I Recall on Fresenius Medical Care's Sanxin Single Use Sterile Syringes

The Food and Drug Administration (FDA) has recently classified the recall of Fresenius Medical Care’s Sanxin Single Use Sterile Syringes as a Class I recall – the most serious type of recall.

The use of these devices, which are integral to hemodialysis treatments, has been identified as potentially causing serious injuries or even death.

Recalled Product Details:

• Product Names: Sanxin Single Use Sterile Syringes

• Product Codes and Part Numbers:

• 10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0

• 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0

• 3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0

• 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

Device Use:

These syringes are crucial components in hemodialysis treatments, specifically used for drawing heparin, a blood-thinning medicine aimed at preventing blood clots. The heparin is then mixed with the patient’s blood through a mechanical syringe pump connected to the Fresenius 2008T hemodialysis machine, which pressurizes the syringes throughout the treatment.

Reason for Recall:

Fresenius Medical Care has initiated the recall due to reported instances of blood or heparin leakage from the syringes and, alarmingly, the discovery of an unidentified black material inside the syringes. The use of these compromised syringes poses severe risks, including blood stream infection (sepsis), blood loss due to leakage, incorrect heparin dosage, and potentially fatal consequences such as blood clotting and embolism.

Reported Incidents:

As of now, there have been 37 reported incidents, although no injuries or deaths have been reported.

Who May be Affected:

Individuals undergoing hemodialysis treatments utilizing Fresenius hemodialysis machines with Sanxin Single Use Sterile Syringes are potentially at risk.

Recall Instructions:

On August 8, 2023, Fresenius Medical Care issued an Urgent Product Recall letter to all affected customers, urging them to:

1. Check their stock for any recalled syringes and place the product in a secure, segregated area.

2. Contact Fresenius Medical Care Renal Therapies Group for instructions on returning the product and receiving credit, specifying if an urgent replacement is needed.

Contact Information:

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.

How to Report a Problem:

Healthcare professionals and consumers are encouraged to report any adverse reactions or quality problems experienced with these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX, referencing FA-2023-17-C RECALL.

This Class I recall emphasizes the urgency and seriousness of the situation, urging immediate attention from healthcare providers, patients, and relevant stakeholders. The FDA continues to closely monitor the situation and will provide updates as necessary.