BEUDAMED
    FDA Recall Open, Classified

    ARROW Endurance Extended Dwell Peripheral Catheter System

    Recall: Z-1826-2023 · Initiated May 19, 2023

    Recall

    Recall Number
    Z-1826-2023
    Event Number
    92377
    Firm
    ARROW INTERNATIONAL Inc.
    FEI Number
    3013162291
    Product Code
    FOZ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 19, 2023
    Posted
    June 21, 2023
    Address
    3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437

    Description

    ARROW Endurance Extended Dwell Peripheral Catheter System

    Reason

    Potential for catheter separation or leakage

    Action

    Arrow International/Teleflex sent customers an "URGENT MEDICAL DEVICE RECALL" letter, via FedEx, on 05/19/2023. Customers were instructed to check for affected products in inventory, immediately discontinue use and quarantine the products and complete and return the Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to [email protected]. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. Should you require further information or support concerning this issue, please contact Customer Service via email, phone, or FAX using the details provided below. Customer Service hours of operation are 8am 7pm EST. Contact: Customer Service Telephone: 1-866-396-2111 FAX: 1-855-419-8507 Email: [email protected] If you have any questions, please contact your local Teleflex sales representative or Teleflex Customer Service.

    Distribution

    Nationwide distribution. International distribution to Canada.

    Quantity

    262,016 units