BEUDAMED
    FDA Recall Terminated

    PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration.

    Recall: Z-0536-2018 · Initiated December 28, 2017

    Recall

    Recall Number
    Z-0536-2018
    Event Number
    79070
    Firm
    Bard Access Systems Inc.
    FEI Number
    3006260740
    Product Code
    LJS
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    December 28, 2017
    Posted
    February 6, 2018
    Terminated
    June 14, 2021
    Address
    605 N 5600 W, Salt Lake City, UT, 84116-3738

    Description

    PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration.

    Reason

    Possible leaks on the 3 Fr. Single lumen and 4 Fr. Dual lumen PowerPICC catheters at the luer hub extension leg junction.

    Action

    Customers were notified via letter on approximately 12/28/2017. Instructions include a reminder that if additional extension sets are attached to the luers of the catheters, they should be appropriately secured as per hospital recommended securement protocol, to refrain from having unsupported extension sets that could put stress on the luer extension leg junction of the catheter, and to notify customers if the product was further distributed. Also, the notification contained a statement that Bard Access is in the process of updating their Instructions for Use to include a statement regarding the importance of properly securing additional extension sets per hospital recommended securement protocol. On 04/11/2018, the recall was expanded and customers were notified via letter, which explained that the previous recall has been expanded to involve return of affected product as well as include product distributed from February 2017 through March 2018. Instructions included to examine inventory for affected product, quarantine and immediately discontinue distribution of the product, complete and return the Business Recall Response Form, arrange for the return of affected product, and notify customers if the product has been further distributed. For distributors, Bard Access Systems requested a customer list so that they could notify their customers.

    Distribution

    Distribution US nationwide.

    Quantity

    53,699 units total