Fresenius Medical Care recalls syringes used during hemodialysis
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The FDA said in a notice that it has classified this case as a Class I recall, the most serious type. Use of these devices may cause serious injuries or death, the agency said.
Fresenius said in a statement that it imports Sanxin Syringes, manufactured by Jiangxi Sanxin Medtec Co., for drawing heparin during a dialysis treatment. “After learning of product complaints, Fresenius Medical Care made the decision to remove all lots of the affected part numbers from the marketplace,” the company said in the statement.
Fresenius sent a product recall notification on Aug. 8 to 1,699 customers in the United States with the information that the company is initiating the voluntary removal of the syringes.
The recall applies to the following affected part numbers:
- 15-R010-0 – 10 mL syringe Luer lock without needle;
- 15-10ML-0 – 10 mL syringe Luer lock with needle; and
- 15-03ML-0 – 3 mL syringe Luer lock with needle #20GX1.
In its notice, the FDA said the recall involves 12,477,300 units, or about 124,773 boxes of 100 syringes each. The syringes are connected to the Fresenius 2008T hemodialysis machine and pressurized for the duration of the hemodialysis treatment, the FDA said.
Use of the affected syringes may cause serious adverse health consequences, including blood stream infection or blood loss due to leakage. Other risks include the wrong heparin dosage, leading to blood clotting, embolism and death, the FDA said. There have been 37 reported incidents and no reported injuries or deaths, the agency wrote. — by Mark E. Neumann
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