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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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Event Detail

Event ID 62971
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 2011-11-08
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415, Carefusion, Leawood, KS 66211, USA Product code 260415, Lot#: 48225 Class II Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging. 67,775 Applicators D-1674-2012
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