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 |
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