Field Correction of Transfer Sets Packed with Humate-P
DATE NOTIFICATION INITIATED:
July 24, 2007
PRODUCT / LOT NUMBER:
Transfer sets packed together with Humate-P (STN# 103960)
MANUFACTURER:
CSL Behring LLC
King of Prussia, PA
REASON:
CSL Behring has identified that blisters of the blue transfer set, which is provided with Humate-P (STN #103960) may have small holes and the transfer set should not be used anymore. The lyophilized product Humate-P and the diluent supplied with the Humate-P are not impacted by the defect in the transfer set.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.