BEUDAMED
    FDA Recall Open, Classified

    Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Medium/Thick, Item Code SIG30AMT

    Recall: Z-2513-2018 · Initiated May 22, 2018

    Recall

    Recall Number
    Z-2513-2018
    Event Number
    80423
    Firm
    COVIDIEN MEDTRONIC
    FEI Number
    1219930
    Product Code
    GDW
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    May 22, 2018
    Posted
    July 19, 2018
    Address
    60 NIDDLETOWN AVE, 2ND F, NORTH HAVEN, CT, 06473

    Description

    Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Medium/Thick, Item Code SIG30AMT

    Reason

    Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

    Action

    On May 22, 2018, all U.S. consignees received an UPDATED URGENT MEDICAL DEVICE RECALL and RETURN FORM notice via Federal Express or certified. The initial notice was sent to impacted customers on April 26, 2018. Customers are advised to take the following required actions: 1. Immediately discontinue use, and quarantine affected products listed 2. Return affected product as indicated. 3. Complete the Recalled Product Return Form even if you do not have inventory and submit by either method below: * Product purchased directly from Medtronic: [email protected] or fax to (800) 895-6140. *Product purchased through distributor: [email protected] or fax it to (203) 492-7719.

    Distribution

    Nationwide U.S.A. Internationally to: Albania, Algeria, Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hungary, Iceland, Ireland, Israel, Italy, Ivory Coast, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malta, Martinique, Moldova, Morocco, Namibia, Netherlands, New Caledonia, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates & United Kingdom