BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-0444-2013 · Reported December 5, 2012

    Enforcement

    Recall Number
    Z-0444-2013
    Event ID
    63583
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Metrex Research, LLC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 5, 2012
    Initiation Date
    September 20, 2011
    Classification Date
    November 27, 2012
    Termination Date
    November 29, 2012
    Address
    28210 Wick Rd, N/A, Romulus, MI, 48174-2639, United States

    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

    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 Info

    Part Number Lot Number 4511 201008270110

    Distribution

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

    Quantity

    3,348 units