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U.S. Department of Health and Human Services

Enforcement Report - Week of September 19, 2012
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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 19207-1004 Class II 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. 3 cases Z-2328-2012
CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in skin prep 16480-0908, 20976-1008, 21283-1009 Class II 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. 16 cases Z-2329-2012
CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution The PV contained in the kit is used in skin prep 20179-1006 Class II 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. 4 cases Z-2330-2012
CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution 14327-0902, 19929-1006 Class II 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. 15 cases Z-2331-2012
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