BEUDAMED
    FDA Recall Terminated

    Enpath Lead Adapter, Ref: 501214. The contents of the inner package have been sterilized by ethylene-oxide gas. Enpath Medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA.

    Recall: Z-0580-2010 · Initiated September 1, 2009

    Recall

    Recall Number
    Z-0580-2010
    Event Number
    53777
    Firm
    Greatbatch Medical
    FEI Number
    2183787
    Product Code
    DTB
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    September 1, 2009
    Posted
    December 29, 2009
    Terminated
    December 17, 2011
    Address
    2300 Berkshire Lane, North Minneapolis, MN, 55441

    Description

    Enpath Lead Adapter, Ref: 501214. The contents of the inner package have been sterilized by ethylene-oxide gas. Enpath Medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA.

    Reason

    The silicone tubing of affected leads was processed outside of validated parameters. Although the material remains biocompatible, test data regarding the performance characteristics are not available.

    Action

    Customers were contacted by phone beginning 09/01/09. They were asked to hold product and determine if they had distributed any product. A written notification followed which identified the product, described the issue and asked for product to be returned. Product was distributed to two consignees and contained the following day. Questions are directed to the company at 612-559-2613.

    Distribution

    CA and MN

    Quantity

    45 units