BEUDAMED
    FDA Recall Terminated

    Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardiopulmonary bypass

    Recall: Z-2160-2018 · Initiated May 14, 2018

    Recall

    Recall Number
    Z-2160-2018
    Event Number
    80076
    Firm
    Maquet Cardiopulmonary Ag Kehler Strasse 31 Rastatt Germany
    FEI Number
    3009507273
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    May 14, 2018
    Terminated
    May 15, 2020

    Description

    Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardiopulmonary bypass

    Reason

    This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.

    Action

    Urgent Medical Device Recall letters were distributed beginning 5/14/18. The letters instructed customers to do the following: 1. Read and understand this notification, and disseminate the information provided to all users, or prospective users, of the affected arterial cannulae. 2. Check your arterial cannula inventory and compare with the Getinge part number, article number and lot number provided on Page 1 of this notification. 3. Remove any affected product that are still in your inventory and prepare it for shipment back to Getinge. 4. Call Getinge Customer Support at 1-888-627-8383 (Press Option 2 and then Option 2) for a Return Authorization (RGA) and for shipping information and label. Customer Support will issue a credit for the product return. 5. Complete, sign and promptly return the filled out response form (Page 4 of this notification) either by email to [email protected] or by fax to 1-973-860-1675.

    Distribution

    Worldwide distribution including US state of VA and Puerto Rico, Australia, Belgium, Brazil, Canada, Chile, Colombia, Cuba, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Iran, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Martinique, Mauritius, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Reunion, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syria, Thailand, Turkey, United Arab Emirates, and United Kingdom.

    Quantity

    470 US