Fresenius Kabi hit with Class I notification for recall
This article was originally published in Clinica
The US FDA has branded Fresenius Kabi’s recall of its red blood cell set as a Class I notice. Fresenius initiated the recall on 18 October, telling its customers to discontinue use of the product after it discovered that the device removed more red blood cells than intended, causing haemodilution. The set is used on the AS104 blood cell separator system. The set is designed to for the depletion or exchange of red blood cells during therapeutic aphaeresis procedures, when blood is removed from the patient and separated into its different components. A total of 255 units are affected by the recall, all manufactured between 1 October 2007 and 30 July 2010.
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