BEUDAMED
    FDA Recall Terminated

    Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

    Recall: Z-1621-2016 · Initiated April 1, 2016

    Recall

    Recall Number
    Z-1621-2016
    Event Number
    73737
    Firm
    Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa
    FEI Number
    2027111
    Product Code
    FZP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 1, 2016
    Posted
    May 6, 2016
    Terminated
    February 7, 2017
    Address
    Margarita, CA, 92688-2650

    Description

    Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

    Reason

    Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels.

    Action

    Customer notification letters were sent on 04/01/16 via UPS. The notification requests that customers check their inventory for recalled products, complete the attached Recall Notification Confirmation Form to acknowledge the recall and indicate if the facility is returing or has already used any of the products. If customers are a distributor it is requested that they notify any facilities to which have been distributed the affected product. Customers are asked to return the Recall Notification Confirmation Form to Applied Medical by emailing to [email protected] or faxing to (949) 713-8921. Customers are to return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical. For product return questions contact Karen Mitchell, Sales Operations Supervisor, RGA Dept. at (949) 713-8622 or by email at [email protected]. For regulatory questions contact Lauren Contursi, at (949) 713-8767 or by email at [email protected].

    Distribution

    U.S. distribution to the following: IL, IN, WY, PA, CA, LA, MN, AZ, OH, OR, CT, WI, NC, AK, NE, MI, KS, FL, MN, TN, SC, MA, MD, KY, TX, GA, TX, NJ, MO, CO, MS, MT, ID, ME, VA, NY, UT, MI, AL, PR, NM, DE, OK, WA, DC, NH, AR Foreign distribution to the following; Australia, Spain, New Zealand, Italy, Israel, Estonia, United Arab Emirates, Germany, Netherlands, France, Kuwait, Korea, Qatar, Mexico, Switzerland, Austria, Bahrain, Lebanon, Brazil, Belgium, United Kingdom, Finland, Japan, Argentina, Ireland, Iran, Denmark, Norway, Colombia, Serbia, Uruguay, Sweden, Canada, Costa Rica, South Africa, Czech Republic, Chile, Finland, India, Thailand, Malaysia

    Quantity

    559,274