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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 CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Recall Number Z-2357-2012
Classification Class I
Code Info 16661-0909, 16662-0909, 17272-0910, 17566-0911, 17566-0911, 17923-1001, 18188-1001, 18195-1001, 18793-1003, 19158-1004
Product Distributed Qty 538 cases
Reason For Recall The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.

Event Detail

Event Id 62132
Product Type Devices
Status Completed
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 US Nationwide Distribution including the states of CO, FL, KS, MA, MI, NJ and PA.
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