Fresenius Kabi LLC, Red Blood Cell (RBC) Exchange Sets used on AS104 Blood Cell Separation Devices: Class I Recall
Posted Dec 21 2010 1:40pm
AUDIENCE: Risk Manager, Hematology
ISSUE: 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.
BACKGROUND: Red Blood Cell (RBC) Set (catalog number 9007601) is used for depletion or exchange of red blood cells during therapeutic apheresis procedures, when blood is removed from the patient and separated into its component parts, on the Fresenius AS 104 Blood Cell Separator Device.
RECOMMENDATION: Customers are instructed to discontinue using, dispensing and distributing the affected product and return product to Fresenius Kabi.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: