Enforcement Report - Week of September 26, 2012
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Product Detail
| Product Description | BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep |
|---|---|
| Recall Number | Z-2360-2012 |
| Classification | Class I |
| Code Info | 14255-0901 |
| Product Distributed Qty | 75 cases & 60 Bottles for reps |
| 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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