BEUDAMED
    FDA Enforcement Class II Terminated

    Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters

    Recall: Z-2170-2017 · Reported June 7, 2017

    Enforcement

    Recall Number
    Z-2170-2017
    Event ID
    77163
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 7, 2017
    Initiation Date
    April 28, 2017
    Classification Date
    May 26, 2017
    Termination Date
    August 3, 2018
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607, United States

    Description

    Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters

    Reason

    Arrow International is notifying each customer who received the affected that product that the kits do not contain important information regarding the 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing.

    Code Info

    ASK-04001-DU9 and ASK-04001-DU10 Device Listing Number D156491 Lot Numbers: 23F15L0593 23F16A0300 23F16B0028 23F16B0523 23F16J0151 23F16K0363 23F16K0431 23F16K0820 23F15L0662 23F16A0298 23F16B0338 23F16C0321 23F16C0632 23F16J0105 23F16K0449

    Distribution

    US Distribution to the state of : NC

    Quantity

    3,918 units