BEUDAMED
    FDA Recall Terminated

    LeMaitre Vascular AnastoClip GC Vessel Closure System-Large Size Models: 4007-03 Large size 3 Pack 4008-03 Large size 10 Pack 4007-07 Large size 1 Pack Manufactured by LeMatire Vascular Inc, Burlington, MA 01803

    Recall: Z-0165-2011 · Initiated September 22, 2010

    Recall

    Recall Number
    Z-0165-2011
    Event Number
    56908
    Firm
    Lemaitre Vascular, Inc.
    FEI Number
    1220948
    Product Code
    HBT
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    September 22, 2010
    Posted
    October 28, 2010
    Terminated
    September 15, 2011
    Address
    63 2nd Ave, Burlington, MA, 01803-4413

    Description

    LeMaitre Vascular AnastoClip GC Vessel Closure System-Large Size Models: 4007-03 Large size 3 Pack 4008-03 Large size 10 Pack 4007-07 Large size 1 Pack Manufactured by LeMatire Vascular Inc, Burlington, MA 01803

    Reason

    Mislabeled size on external packaging: The contents section listed on the Tyvek lid labels of the Medium and Large sizes incorrectly identified the size of the clip as XL, while the device inside was either a Medium or Large size.

    Action

    LeMaitre Vascular issued an Urgent AnastoClip GC Device Field Safety Notice letter dated Sepember 28, 2010 identifying the affected devices and actions to be taken by customers. The letter contains a form that is requested to be returned to LeMaitre Vascular as record of notification and reconciliation. The letter provides an option for the notified hospital to return the affected product for replacement if unused or if they simply wish to have it corrected. Customers can contact LeMaitre Customer Service for replacement at 800 628-9470.

    Distribution

    Nationwide Distribution: to the states of CA, FL, GA, IL, IN, LA, MD, MS, NJ, OK, OR, and TX.

    Quantity

    108 units