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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Urgent Product Recall - Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK Unit

DATE RECALL INITIATED: April 24, 2013

PRODUCT / LOT NUMBER

Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK Unit

Product Code 4R1584
Lot Number: FM13A15027

MANUFACTURER:

Fenwal
Lake Zurich, IL

REASON:

Fenwal has initiated a voluntary Urgent Product Recall of one lot (FM13A15027) of product code 4R1584, Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK unit. Fenwal identified a labeling issue with this batch of Product Code 4R1584 in which the platelet container is incorrectly labeled as “AS-1 Red Blood Cell Adenine-Saline added”. To date, there is only one reported occurrence of this incident. No safety concerns have been raised, however, Fenwal is recommending that customers immediately check their inventory, discontinue the use of this product, and return the impacted product to Fenwal.


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.