Fresenius Kabi LLC, Red Blood Cell (RBC) Exchange Sets used on AS104 Blood Cell Separation Devices: Class I Recall
MedSun: Newsletter #56, January 2011

FDA MedWatch Safety Alert

Use of the recalled product has led to removal of greater amounts of red blood cells than intended, resulting in hemodilution. 255 units are subject to this recall, including Red Blood Cell (RBC) Set (catalog number 9007601), lot numbers WKT252, YLT061, ZCT011, and ZGT052, manufactured from October 1, 2007 to July 30, 2010. Customers are instructed to discontinue using, dispensing and distributing the affected product and return product to Fresenius Kabi.

Additional Information:

FDA MedWatch Safety Alert. Fresenius Kabi LLC, Red Blood Cell (RBC) Exchange Sets used on AS104 Blood Cell Separation Devices: Class I Recall. December 21, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm237707.htm


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