BEUDAMED
    FDA Recall Terminated

    Product is Reprocessed Ethicon Bladeless Trocars. Model: 35NLT, 35NST, 35OL

    Recall: Z-1212-06 · Initiated March 17, 2006

    Recall

    Recall Number
    Z-1212-06
    Event Number
    35506
    Firm
    Vanguard Medical Concepts, Inc
    FEI Number
    1000132435
    Product Code
    NLM
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    March 17, 2006
    Posted
    July 12, 2006
    Terminated
    October 31, 2008
    Address
    5307 Great Oak Dr, Lakeland, FL, 33815

    Description

    Product is Reprocessed Ethicon Bladeless Trocars. Model: 35NLT, 35NST, 35OL

    Reason

    Review of complaints and testing show that the distal tip of the trocars may separate while in use.

    Action

    The firm sent recall notification letters to its consignees on 3-17-2006. They were instructed to discontinue use of the 35NLT, 35NST and 35Ol Reprocessed Optiview Trocars with expiration date of 12/20008 or earlier immediately. Any of this product in inventory were to be returned to the manufacturer for credit. The firm also offered the assistance of its representatives in returning all affected profucts. The investigation is ongoing, and corrective actions associated with the root cause of tips breaking off have been identified and are being implemented.

    Distribution

    Nationwide.

    Quantity

    13,842