Home / Recalls / Metrex Research, LLC. / Z-0444-2013

Z-0444-2013 Class II Terminated

Recalled by Metrex Research, LLC. — Romulus, MI

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