Simplifying Global Compliance
FDAnews Device Daily Bulletin
Class I Recall Issued on Dialysis Tools
Sept. 5, 2012
The FDA has classified Fresenius Medical Care’s recent warning of the company’s GranuFlo and NaturaLyte dialysis products a Class I recall. Due to the concentration levels of acetate or sodium diacetate within the devices, inappropriate prescriptions could lead to a high serum bicarbonate level in patients undergoing hemodialysis. Potential adverse events include cardiac arrest or death.
The GMP Letter
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