BEUDAMED
    FDA Recall Terminated

    10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage

    Recall: Z-1418-2014 · Initiated March 20, 2014

    Recall

    Recall Number
    Z-1418-2014
    Event Number
    67757
    Firm
    Aspen Surgical Products, Inc.
    FEI Number
    3002750084
    Product Code
    GCY
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    March 20, 2014
    Posted
    April 7, 2014
    Terminated
    November 25, 2014
    Address
    6945 Southbelt Dr Se, Caledonia, MI, 49316-7664

    Description

    10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage

    Reason

    The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.

    Action

    Aspen Surgical sent an Urgent Medical Device Recall letter dated March 20, 2014, to all affected customers and will be carried out at the distributor and retailer level, which can include doctor's offices, hospitals, and clinics. The distributor was instructed to contact their local FDA District office, conduct a sub-recall and to forward this Recall Notification and Response form to their retailers. A written notification to the consignees was sent by certified mail. Aspen has given the customers the option to either 1.) Return the product 2.) Destroy the product with a Certificate of Destruction to be provided to Aspen. Any returned product to Aspen will be put on MRB and dispositioned by Quality. The returned product will not be reprocessed. In order to determine effectiveness of the recall, any consignee that does not return the response form and/or product, will be contacted within three weeks of receipt of the Recall letter. Non-responders will be contacted a total of three (3) times in order to verify the effectiveness of the recall activity. Customers with questions were instructed to call 888-364-7004, ext 177 or 1-888-364-7004, ext. 156. For questions regarding this recall call 616-698-7100.

    Distribution

    Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.