BEUDAMED
    FDA Recall Terminated

    CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product Usage: Usage: The PVP contained in the kit is used in skin prep

    Recall: Z-2350-2012 · Initiated September 30, 2011

    Recall

    Recall Number
    Z-2350-2012
    Event Number
    62132
    Firm
    Custom Medical Specialties, Inc.
    FEI Number
    3005474845
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    September 30, 2011
    Posted
    September 20, 2012
    Terminated
    April 29, 2013
    Address
    330 East Main Street, Pine Level, NC, 27568

    Description

    CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product Usage: Usage: The PVP contained in the kit is used in skin prep

    Reason

    The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.

    Action

    Custom Medical Specialties sent an Urgent Medical Device Recall letter dated September 27, 2011 and a follow-up letter dated September 4, 2012 to all affected customers. The letter identified the affected product, problem, and actions to be taken. The letter requested that customers inspect inventory, discontinue use and return any remaining affected products. A Return Authorization Number and shipping number will be given to customer by calling 919-202-8462 ext 205. Customers were instructed to complete and return the attached Acknowledgement and Return Product form.

    Distribution

    US Nationwide Distribution including the states of CO, FL, KS, MA, MI, NJ and PA.

    Quantity

    3 cases