Metrex Research, LLC.: Medical Device Recall in 2012 - (Recall #: Z-0444-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 20, 2011

Date Posted: December 5, 2012

Recall Number: Z-0444-2013

Event ID: 63583

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).

Status: Terminated

Product Quantity: 3,348 units

Code Information:

Part Number Lot Number 4511 201008270110

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated