BEUDAMED
    FDA Recall Terminated

    Arrow Two-Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132

    Recall: Z-1118-2019 · Initiated January 10, 2019

    Recall

    Recall Number
    Z-1118-2019
    Event Number
    82070
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    January 10, 2019
    Terminated
    June 4, 2020
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    Description

    Arrow Two-Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132

    Reason

    The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct

    Action

    Teleflex issued Urgent Medical Device Notification to US consignee notification letter on 10th January 2019 via FedEx 2-day mail. Actions to be taken to remove product from the facilities: A: The affected customer is instructed to take the following actions: 1. Place a copy of this notification with each unit of affected product currently in your inventory. 2. After step (1) is complete, fill out the enclosed Acknowledgement Form

    Distribution

    FL, NC

    Quantity

    None (US)