BEUDAMED
    FDA Recall Terminated

    Medtronic Neurosurgery C/N 3805-014 Peelaway Introducer Sheath, Disposable 14 F

    Recall: Z-1110-05 · Initiated July 5, 2005

    Recall

    Recall Number
    Z-1110-05
    Event Number
    32595
    Firm
    Medtronic Neurosurgery
    FEI Number
    3015531529
    Product Code
    GWG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 5, 2005
    Posted
    August 10, 2005
    Terminated
    June 26, 2008
    Address
    125 Cremona Dr, Goleta, CA, 93117-5503

    Description

    Medtronic Neurosurgery C/N 3805-014 Peelaway Introducer Sheath, Disposable 14 F

    Reason

    Cracked hubs/handles and/or improper peeling of the sheath during use.

    Action

    Firm sent recall letters by Fedex on July 5, 2005 to all customers.

    Distribution

    Nationwide and to Canada, Australia, India, France, Italy, Netherlands, Portugal, South Africa, Spain, Switzerland, Turkey, United Kingdom.

    Quantity

    366