BEUDAMED
    FDA Enforcement Class II Terminated

    CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in skin prep

    Recall: Z-2328-2012 · Reported September 19, 2012

    Enforcement

    Recall Number
    Z-2328-2012
    Event ID
    62875
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Custom Medical Specialties, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 19, 2012
    Initiation Date
    September 30, 2011
    Classification Date
    September 7, 2012
    Termination Date
    September 10, 2012
    Address
    330 East Main Street, N/A, Pine Level, NC, 27568, United States

    Description

    CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in skin prep

    Reason

    The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.

    Code Info

    19207-1004

    Distribution

    Nationwide Distribution including GA, MI, NY, and PA.

    Quantity

    3 cases