Enforcement Report - Week of December 5, 2012
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Product Detail
| Product Description | Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter. |
|---|---|
| Recall Number | Z-0444-2013 |
| Classification | Class II |
| Code Info | Part Number Lot Number 4511 201008270110 |
| Product Distributed Qty | 3,348 units |
| Reason For Recall | The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve 4511, which fits 11mm light guides, actually contain Pinnacle Cure Sleeves that fit 7mm or 8mm light guides (part number 4500). |
Event Detail
| Event Id | 63583 |
|---|---|
| Product Type | Devices |
| Status | Terminated |
| Recalling Firm | Metrex Research, LLC. |
| City | Romulus |
| State | MI | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2011-09-20 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe. |
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