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Metrex Research, LLC. recalls Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to pr
Recalled December 5, 2012 · FDA recall Z-0444-2013 · Metrex Research
Hazard
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). · FDA Class II
Units
3,348 units
Sold at
Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe.
Description
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).
Product
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.
Manufacturer(s)
Metrex Research, LLC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →