BEUDAMED
    FDA Recall Terminated

    Sheath Obturator, introducer, catheter. Obturator Accessory Kit Reorder number 406405, a 6 Fr, 15 cm length Obturator supplied as a 10-pack box with 10 Individually packaged Obturators. Sterile EO. Single use. St. Jude medical, DAIG Division, Inc., Minnetonka, MN 55345-2126 USA

    Recall: Z-0125-06 · Initiated September 20, 2005

    Recall

    Recall Number
    Z-0125-06
    Event Number
    33702
    Firm
    St. Jude Medical Daig Division
    FEI Number
    2182269
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 20, 2005
    Posted
    November 3, 2005
    Terminated
    July 22, 2006
    Address
    14901 Deveau Pl, Minnetonka, MN, 55345-2126

    Description

    Sheath Obturator, introducer, catheter. Obturator Accessory Kit Reorder number 406405, a 6 Fr, 15 cm length Obturator supplied as a 10-pack box with 10 Individually packaged Obturators. Sterile EO. Single use. St. Jude medical, DAIG Division, Inc., Minnetonka, MN 55345-2126 USA

    Reason

    A lot of product contains a 6F Obturator with a hub that is incorrectly marked as 5 instead of the appropriate 6. The Obturator is correctly sized (6F) per the labeling on both the sterile bag and shelf carton.

    Action

    A letter dated 09/20/05 was sent to all customers explaining the issue and instructed customers that a St. Jude Medical Representative will facilitate in the product removel process. Full credit will be issued.

    Distribution

    CA, FL, KY, IL, MN, NY, OH, TN, VA & WI

    Quantity

    2000