BEUDAMED
    FDA Recall Terminated

    Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S, Product usage: The devices are intended for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling.

    Recall: Z-1223-2018 · Initiated November 28, 2017

    Recall

    Recall Number
    Z-1223-2018
    Event Number
    79425
    Firm
    Cook Vascular Inc.
    FEI Number
    2522007
    Product Code
    LJT
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 28, 2017
    Terminated
    October 3, 2018
    Address
    1186 Montgomery Ln, Vandergrift, PA, 15690-6065

    Description

    Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S, Product usage: The devices are intended for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling.

    Reason

    Non-coring needle provided with the Cook Vital-Port Vascular Assess System (Vital-Port) may cut or dislodge a core or sliver of material from the Vital-Port septum when the non-coring needle is inserted into the Vital-Port. This needle is used on the initial implant of the Vital-Port. Vital-Port products that have been successfully placed in patients are not impacted by this recall.

    Action

    Removal for all non-expired lots of the Cook Vital-Port Vascular Access System. Written recall communication letters will be mailed via courier to US Consignees.plan to STORE recalled product(s)? (if returned) Recalled products will be returned to global regional distribution warehouses to be quarantined in a marked receiving area of returned goods. 8.9 Provide plan for final DISPOSITION for recalled product(s)? All recalled products will be destroyed at the regional distribution warehouses. A certificate of destruction will be provided upon completion of destruction prior to the completion of the recall. Products remaining in the control of Cook will be assessed for rework to replace the non-coring needle.

    Distribution

    The devices have been distributed within the United States and the following countries: United Arab Emirates, Argentina, Austria, Australia, Barbados, Belgium, Bulgaria, Bermuda, Brazil, Canada, Switzerland, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Spain, Finland, Faroe Islands, France, United Kingdom, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Iceland, Italy, Jamaica, Jordan, Japan, Kenya, South Korea, Kuwait, Lebanon, Latvia, Morocco, Macedonia, Mexico, Netherlands, New Zealand, Oman, Panama, Poland, Portugal, Serbia, Saudi Arabia, Sweden, San Marino, El Salvador, Turkey, Trinidad & Tobago, Ukraine, Uruguay, Venezuela, Virgin Islands, Kosovo, China, and South Africa.

    Quantity

    31,006 Units