BEUDAMED
    FDA Recall Terminated

    Enseal TRIO Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05

    Recall: Z-2635-2010 · Initiated July 9, 2010

    Recall

    Recall Number
    Z-2635-2010
    Event Number
    56292
    Firm
    Ethicon Endo-Surgery Inc
    FEI Number
    1527736
    Product Code
    NLM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 9, 2010
    Posted
    September 30, 2010
    Terminated
    February 14, 2011
    Address
    4545 Creek Rd, Cincinnati, OH, 45242-2803

    Description

    Enseal TRIO Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05

    Reason

    The weld that connects the electrode to the active rod was separated. This connection is critical to the proper function of these devices. If the weld is separated, the product will not deliver energy to the jaws, resulting in the potential for a cut/transection without a seal. Ethicon Endo-Surgery identified this issue during a routine finished goods quality inspection.

    Action

    Ethicon Endo-Surgery issued an Urgent: Device Recall, Event 2193 letter dated July 19, 2010 identifying the affected device, the issue prompting the recall, and actions to be taken by consignees. Consignees were instructed: Do not use the affected product. Identify and quarantine affected product from inventory. Complete the Business Reply form and fax to Stericycle at 877-597-9580 within three days To return product, place it in a box with a copy of the Business Reply form and mail to Stericycle using the pre-printed UPS shipping label. Replacement product should be received by the customer within 60 days of return of affected product. Customers can contact Stericycle about this recall at 877-243-7314 and referencing Event 2193.

    Distribution

    Nationwide Distribution to the following states: AZ, AL, AZ, CA, CO, CT, FL, GA, IN, KY, MA, MD, MI, MO, MS, NC, NV, NY, OH, PA, TN, TX, WA, and WV.

    Quantity

    396 instruments