Reported Dec 5, 2012 · Terminated
Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to…
Metrex Research, LLC.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Metrex Research, LLC. · 28210 Wick Rd · Romulus, MI · 48174-2639
Is this the product you have?
- 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.
- Lot codes and dates
- Part Number Lot Number 4511 201008270110
- Amount recalled
- 3,348 units
Where it was sold
- Nationwide
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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