BEUDAMED
    FDA Recall Terminated

    MX6160R1, Custom CIPER (Comprehensive Intracranial Presssure Evaluation and Relief) System. The product is packaged in a tyvek pouch and is sold sterile. The product is labeled on the tyvek pouch with a stick-on label that reads in part ,''medex Dublin, OH 43016 USA***STERILE**MX6160R1 ** Custom CIPER**Lot #:**Latex Free***SINGLE USE''

    Recall: Z-0811-06 · Initiated November 18, 2005

    Recall

    Recall Number
    Z-0811-06
    Event Number
    35119
    Firm
    Medex Inc
    FEI Number
    1526863
    Product Code
    GWM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 18, 2005
    Posted
    April 26, 2006
    Terminated
    January 22, 2008
    Address
    6250 Shier Rings Rd, Dublin, OH, 43016-1270

    Description

    MX6160R1, Custom CIPER (Comprehensive Intracranial Presssure Evaluation and Relief) System. The product is packaged in a tyvek pouch and is sold sterile. The product is labeled on the tyvek pouch with a stick-on label that reads in part ,''medex Dublin, OH 43016 USA***STERILE**MX6160R1 ** Custom CIPER**Lot #:**Latex Free***SINGLE USE''

    Reason

    The product is labeled as 'Latex Free'; however, one of the components of the finished product may contain latex.

    Action

    The firm sent a recall letter dated 11/18/2005, via Certified mail to all of their customers. In the letter, the firm requests that the consignee telephone the firm and obtain a Return Authorization number in order to return the recalled product.

    Distribution

    The recalled device was distributed to a single direct account customer located in Alabama and to

    Quantity

    2480 devices