BEUDAMED
    FDA Recall Terminated

    DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.

    Recall: Z-2768-2017 · Initiated June 22, 2017

    Recall

    Recall Number
    Z-2768-2017
    Event Number
    77641
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    DXS
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    June 22, 2017
    Posted
    July 10, 2017
    Terminated
    July 22, 2020
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.

    Reason

    Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

    Action

    Medtronic sent an Urgent Medical Device Recall letter dated June 22, 2017, to all affected consignees, both in the US, via 2-Day UPS Mail, and OUS, via local methods. Consignees were asked to quarantine and return any affected product. No recommendations were made for patients who have undergone procedures using affected product. US consignees were asked to complete and return a recall notification confirmation certificate to fax 651-367-0612, indicating that they were informed of the recall and executed the appropriate action. Customers with questions were instructed to contact Customer Service at 1-800-854-3570. For questions regarding this recall call 763-526-2494.

    Distribution

    Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Denmark, El Salvador, France, Georgia, Germany, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Macedonia, Moldova, Netherlands, New Zealand, Nigeria, Norway, Poland, Romania, Russian Federation, Slovenia, Spain, Thailand, Turkey, & United Kingdom.

    Quantity

    63053 (48180 US) (14873 OUS)