Anticoagulant Citrate Phosphate Dextrose Solution

Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK Unit By Fenwal: Recall - Labeling Issue Identified

Read the MedWatch Safety Alert, including links to the Recall at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350275.htm
AUDIENCE: Risk Manager, Health Professional, Pharmacy
ISSUE: 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”. 
BACKGROUND: To date, there is only one reported occurrence of this incident and no safety concerns have been raised.
RECOMMENDATION: Fenwal is recommending that cus

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