BEUDAMED
    FDA Recall Terminated

    Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port. 9 Fr. Introducer Kit Ref Product No. AP-06013.

    Recall: Z-0286-2007 · Initiated September 29, 2006

    Recall

    Recall Number
    Z-0286-2007
    Event Number
    36522
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    LJT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 29, 2006
    Posted
    December 19, 2006
    Terminated
    June 4, 2007
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    Description

    Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port. 9 Fr. Introducer Kit Ref Product No. AP-06013.

    Reason

    Catheter has separated from the infusion port body.

    Action

    The recall notification was sent out to their US customers on 9/29/2006.

    Distribution

    Nationwide. The firm is NOT recalling from international accounts.

    Quantity

    331