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Recall Observatory FDA recall evidence

Device 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.

Z-0444-2013

September 20, 2011

Class II

Product summary

Firm
Metrex Research, LLC.
Event
Event 63583
Status
Terminated
Classification
Class II
Quantity
3,348 units
Official record key
device-enforcement:Z-0444-2013

Official wording

Reason: 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).

Code information: Part Number Lot Number 4511 201008270110

Distribution pattern: Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    labeling error