Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of...
FDA Recall #Z-0444-2013 — Class II — September 20, 2011
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.
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).
Recalling Firm
Metrex Research, LLC. — Romulus, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3,348 units
Distribution
Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe.
Code Information
Part Number Lot Number 4511 201008270110
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated