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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 customers immediately check their inventory, discontinue the use of this product, and return the impacted product to Fenwal.
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
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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