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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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Product Detail

Product Description 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
Recall Number D-1674-2012
Classification Class II
Code Info Product code 260415, Lot#: 48225
Product Distributed Qty 67,775 Applicators
Reason For Recall Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.

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