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U.S. Department of Health and Human Services

Enforcement Report - Week of December 5, 2012

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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
Distribution Pattern Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Part Number Lot Number 4511 201008270110 Class II 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). 3,348 units Z-0444-2013