FDA-Device2012-12-05Class II
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.
Metrex Research, LLC.
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).
Sold states
Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe.
Affected count
3,348 units
Manufactured in
28210 Wick Rd, N/A, Romulus, MI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0444-2013Don't want to check this manually?
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