BEUDAMED
    FDA Recall Terminated

    Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.

    Recall: Z-2202-2016 · Initiated June 2, 2016

    Recall

    Recall Number
    Z-2202-2016
    Event Number
    74489
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    DQX
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    June 2, 2016
    Posted
    July 12, 2016
    Terminated
    August 21, 2017
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    Description

    Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.

    Reason

    Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits.

    Action

    Arrow International mailed an Urgent Medical Device Recall Notification letter and acknowledgement form dated June 20, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to 1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above. 2. Inspect affected product within your control to identify if the shipping corrugate label correctly identifies the products inside the shipping carton. Products with an incorrect label on the shipping carton can be returned to Arrow. 3. Once you have completed inspection of all of the products from your own inventory, check the box on the enclosed Acknowledgment Form that indicates that you have completed the inspection and fax it to 1-855-419-8507, Attn: Customer Service, or email it to [email protected]. For questions contact your local sales representative or Customer Service at 1-866-246-6990.

    Distribution

    US distribution in the states of TN and KY.

    Quantity

    50 units in total