Fresenius Medical Care's Leaked Internal Memo Leads to FDA Class I Recall
Published: Aug 02, 2012
A Class I recall is the most serious kind of recall the FDA can issue. This action typically involves products the agency believes will cause serious medical problems or even death in users. In the case of the Granuflo recall (as well as the recall of Naturalyte), more than 900 cases of cardiac arrest were reported in patients at the Fresenius centers during a single year. The recall involves both the Naturalyte Liquid Acid concentrate and the Naturalyte Granuflo powder solution. The FDA issued the Class I Naturalyte recall, as well as a Granuflo recall, amid growing reports of Fresenius dialysis problems and adverse side effects from using Granuflo.