Fresenius Medical Care Recalls Few Models of Haemodialysis Machines for Potential Exposure to Toxic Substances in the US
Shots:
- FDA has guided FMC to recall 2008 series Haemodialysis Machine distributed between Aug’08 to Jun’22 (n=207). FDA identified this recall as Class I (most serious recall)
- The reason for the recall is the potential exposure of patients to non-dioxin-like polychlorinated biphenyl acids (PCBAs), which may leach from certain silicone tubing used in the machines' hydraulics and dialysate lines. While no fatalities have been reported, long-term exposure could lead to SAEs
- These haemodialysis machines work as artificial kidney, purifying the blood by removing toxins & excess water. FMC has already shared corrective action plan with patients which includes information of No action required for devices manufactured after Oct’22
Ref: FDA | Image: Fresenius Medical Care
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
