Enforcement Report - Week of September 19, 2012
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Product Detail
| Product Description | CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in skin prep |
|---|---|
| Recall Number | Z-2329-2012 |
| Classification | Class II |
| Code Info | 16480-0908, 20976-1008, 21283-1009 |
| Product Distributed Qty | 16 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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