BEUDAMED
    FDA Recall Terminated

    Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.

    Recall: Z-2772-2016 · Initiated February 17, 2016

    Recall

    Recall Number
    Z-2772-2016
    Event Number
    74898
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    LJS
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    February 17, 2016
    Terminated
    October 18, 2017
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    Description

    Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.

    Reason

    Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.

    Action

    The firm, Arrow International, sent an "Urgent Medical Device Recall Notification" letter dated 02/19/2016 via FedEx 2-day delivery to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any of the affected products found; return product-a customer service representative will contact you with a RGA number and instructions; and complete and return the enclosed Recall Acknowledgement Form via fax to 1-855-419-8507 Attn: Customer Service or email to [email protected], even if you do not have no affected product. If you have any questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

    Distribution

    US Distribution to states of: NC, OH, FL, and MD.

    Quantity

    6,121 units in total