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
Product summary
- 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
labeling error