FDAFDA · Food and drugs·Recall number Z-0444-2013
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.
Published December 5, 2012 · Recall initiated: September 20, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Metrex Research, LLC.
- Distributor
- Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe.
- Lot
- Part Number Lot Number 4511 201008270110
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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