Z-0444-2013 Class II Terminated
FDA device recall Z-0444-2013 was initiated by Metrex Research, LLC. on September 20, 2011 and is designated Class II. 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 gu… The recall status is terminated (terminated November 29, 2012). Affected quantity: 3,348 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 5, 2012
- Initiation Date
- September 20, 2011
- Termination Date
- November 29, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,348 units
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).
Distribution Pattern
Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe.
Code Information
Part Number Lot Number 4511 201008270110