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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Field Correction of Transfer Sets Packed with Humate-P - CSL Behring LLC

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.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448
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