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U.S. Department of Health and Human Services

Enforcement Report - Week of September 19, 2012

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Product Detail

Product Description CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in skin prep
Recall Number Z-2328-2012
Classification Class II
Code Info 19207-1004
Product Distributed Qty 3 cases
Reason For Recall The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.

Event Detail

Event Id 62875
Product Type Devices
Status Terminated
Recalling Firm Custom Medical Specialties, Inc.
City Pine Level
State NC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-09-30
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including GA, MI, NY, and PA.
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