Fresenius Medical Care is increasing its Class I recall of syringes from about 370,000 to more than 12 million, the FDA said Nov. 15.
The company is pulling 12,477,300 syringes from the market because of reports of blood or heparin leaking and "an unknown black material" found within the product. The issue can cause sepsis, blood loss, incorrect heparin doses and death. Fresenius Medical Care has received 37 incident reports and zero injuries or deaths.
The affected Sanxin Single Use Sterile Syringes are 10 milliliter Luer Lock with needle and without needle, and the 3 milliliter Luer Lock with a needle. They were distributed between April 2021 and August 2023.
"Fresenius Medical Care’s top priority is to always provide safe, high-quality and life-sustaining acute and chronic dialysis therapy," a spokesperson told Becker's. "Fresenius Medical Care serves as the importer of Sanxin Syringes, manufactured by Jiangxi Sanxin Medtec Co. After learning of product complaints, Fresenius Medical Care made the decision to remove all lots of the affected part numbers from the marketplace."