BEUDAMED
    FDA Recall Terminated

    Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product Code:AK-42854-P1A - Product Usage: The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.

    Recall: Z-2556-2019 · Initiated August 6, 2019

    Recall

    Recall Number
    Z-2556-2019
    Event Number
    83593
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    August 6, 2019
    Terminated
    September 29, 2020
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    Description

    Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product Code:AK-42854-P1A - Product Usage: The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.

    Reason

    Products may contain the incorrect banner card within the kit

    Action

    Arrow International issued notification dated 8/6/19 stating problem, health risk and action to take: If you have affected stock in inventory, immediately discontinue use and quarantine any products with the product codes and lot numbers. 2. Inspect affected products within your control to confirm the product code on the lidstock matches the product code on the banner card of the same kit. Products confirmed to have an incorrect banner card should be returned to Arrow International. Products which properly match should not be returned. 3. If you have product with an incorrect banner card, please complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email to [email protected]. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. 4. If you have no affected stock, please complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. Questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.

    Distribution

    US Nationwide distribution.

    Quantity

    231 units