BEUDAMED
    FDA Recall Terminated

    ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B

    Recall: Z-1194-2018 · Initiated December 15, 2017

    Recall

    Recall Number
    Z-1194-2018
    Event Number
    79474
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    FOZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 15, 2017
    Posted
    March 14, 2018
    Terminated
    July 18, 2019
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    Description

    ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B

    Reason

    Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries.

    Action

    Notification letters were sent to consignees with the following instructions: 1. If you have affected stock, quarantine so that the affected products can be returned to Arrow. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to Arrow. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to Arrow.

    Distribution

    Distributed in the following U.S. states: CO, FL, IL, NC, PA, SC, and TX.

    Quantity

    305