BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2170-2017 · Initiated April 28, 2017

    Recall

    Recall Number
    Z-2170-2017
    Event Number
    77163
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    OBJ
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    April 28, 2017
    Terminated
    August 3, 2018
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    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.

    Action

    Arrow International sent an Urgent Medical Device Notification letter dated May 2, 2017, to all affected customers to inform them of the issue. The letter will instruct the distributor to notify their customers if the product was further distributed and to return a completed acknowledgement form indicating the amount of units on hand. For further questions, please call (610) 378-0131.

    Distribution

    US Distribution to the state of : NC

    Quantity

    3,918 units