BEUDAMED
    FDA Recall Terminated

    Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery, Product Code: 5DCD, Ethicon Endo-Surgery, Inc, Cincinatti, OH 45242

    Recall: Z-0565-2008 · Initiated November 6, 2007

    Recall

    Recall Number
    Z-0565-2008
    Event Number
    45869
    Firm
    Ethicon Endo-Surgery Inc
    FEI Number
    1527736
    Product Code
    GDI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 6, 2007
    Posted
    January 29, 2008
    Terminated
    December 9, 2009
    Address
    4545 Creek Rd, Cincinnati, OH, 45242-2803

    Description

    Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery, Product Code: 5DCD, Ethicon Endo-Surgery, Inc, Cincinatti, OH 45242

    Reason

    Sterility (package integrity) compromised; Damaged packaging may have compromised the sterility of the devices.

    Action

    Endopath sent consignees an Urgent Device Recall notification letter on or about 11/15/07, informing them that the possibility exists that damage to the packaging of this product may have compromised the sterility of the product. The firms were told to examine their inventory, and remove all affected product. All consignees were instructed to complete the Business Reply Form; even if they did not have any product. Recalled products are to be returned to Ethicon for a credit.

    Distribution

    Worldwide, USA including states of AL, AR, AZ, CA, CO, DE, FL, GA, IL, KS, KY, LA, MA, MN, MO, MS, NC, NJ, NV, NY, OH, PA, RI, TN, TX, AND WA, and countries of Austria, Belgium, Canada, China, Colombia, Czech Republic, Ecuador, Egypt, Greece, Hong Kong, Italy, Japan, Korea, Mexico, Portugal, Puerto Rico, Republic of Panama, South Africa, Spain, Sweden, Taiwan, Turkey, United Kingdom, and Venezuela.

    Quantity

    2,844