BEUDAMED
    FDA Recall Terminated

    Kendall Curity Disposable Laparotomy Sponges, 12 in x 12 in, Sterile Product Number: 6034

    Recall: Z-0382-04 · Initiated January 8, 2004

    Recall

    Recall Number
    Z-0382-04
    Event Number
    28090
    Firm
    Kendall Healthcare Products Co
    FEI Number
    1282497
    Product Code
    NAD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 8, 2004
    Posted
    July 20, 2004
    Terminated
    May 15, 2012
    Address
    15 Hampshire St, Mansfield, MA, 02048-1113

    Description

    Kendall Curity Disposable Laparotomy Sponges, 12 in x 12 in, Sterile Product Number: 6034

    Reason

    Sterility compromised due to lack of package seal integrity

    Action

    Kendall issued Recall letters by US Mail to all customers on January 8, 2004, requesting product be returne and dealer customers be notified.

    Distribution

    AL, AZ, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO,NC NE, NJ, NY, OH, PA, RI, TN, TX, VA, WA, WI, WV.

    Quantity

    188 cases