FDA MedWatch - Fresenius Kabi LLC, Red Blood Cell (RBC) Exchange Sets used on AS104 Blood Cell Separation Devices: Class I Recall

[FDA MedWatch <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - Fresenius Kabi LLC, Red Blood Cell (RBC) Exchange Sets used on AS104 Blood Cell Separation Devices: Class I Recall

Fresenius Kabi LLC, Red Blood Cell (RBC) Exchange Sets used on AS104 Blood Cell Separation Devices: Class I Recall

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:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm237707.htm

 

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