Enforcement Report - Week of February 6, 2013
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Product Detail
| Product Description | Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy. |
|---|---|
| Recall Number | Z-0759-2013 |
| Classification | Class II |
| Code Info | All lots |
| Product Distributed Qty | 344 pieces |
| Reason For Recall | A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions. |
Event Detail
| Event Id | 61879 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Varian Medical Systems, Inc. |
| City | Charlottesville |
| State | VA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-04-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | US Nationwide Distribution |
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