After GranuFlo Recall, FMC Machines Recalled
On January 15, 2014, Fresenius Medical Care (FMC), the largest dialysis provider in the world, recalled over 112,000 machines from the United States, Canada, and Mexico. The FDA posted an official announcement on their website.
This announcement comes on the coattails of over 400 GranuFlo lawsuits filed against Fresenius.
As cited in the FDA announcement, the machines must be recalled because the saline bag attached to them is not filling correctly, which could potentially harm patients.
When the FDA announces the recall of a product such as GranuFlo or dialysis machines, the recall is categorized into Class I, Class II, or Class III. As the most critical classification, Class I recalls may result in the product being withdrawn from the market entirely, as was the case with the recent GranuFlo recall. Unlike the Class I recall of GranuFlo, the recall of these Fresenius manufactured dialysis machines has been declared a Class II recall. According to the FDA, a Class II recall is issued when the product causes temporary and/or reversible health problems or there is a slight possibility of a serious health complication.