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U.S. Department of Health and Human Services

Enforcement Report - Week of October 10, 2012

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Event Detail

Event ID 62900
Product Type Drugs
Status Completed
Recalling Firm Carefusion 213, Llc
City El Paso
State TX
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-04-23
Initial Firm Notification of
Consignee or Public
Distribution Pattern IL, MO, and NJ

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25 Applicators per Carton, Single Use, Latex Free, Applicator is STERILE if package is intact, NDC 54365-400-01. Lot 52894, Product Code: 260400 Class II Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing. 576 Cartons D-004-2013