BEUDAMED
    FDA Recall Terminated

    Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode array of ten electrodes. The Edi Catheter is intended for: - Detecting diaphragmatic electrical activity, (Edi signals) by which the two ventilator modes NAVA and NIV NAVA can be controlled. - Detecting diaphragmatic electrical activity, (Edi signals) by which the respiratory drive from the brain can be monitored. - administrating nutrition, fluids and medications by the naso-gastricenteric route.

    Recall: Z-1221-2019 · Initiated March 20, 2019

    Recall

    Recall Number
    Z-1221-2019
    Event Number
    82533
    Firm
    GETINGE US SALES LLC
    FEI Number
    3012092534
    Product Code
    PIF
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 20, 2019
    Terminated
    April 8, 2020
    Address
    45 BARBOUR POND DR, WAYNE, NJ, 07470

    Description

    Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode array of ten electrodes. The Edi Catheter is intended for: - Detecting diaphragmatic electrical activity, (Edi signals) by which the two ventilator modes NAVA and NIV NAVA can be controlled. - Detecting diaphragmatic electrical activity, (Edi signals) by which the respiratory drive from the brain can be monitored. - administrating nutrition, fluids and medications by the naso-gastricenteric route.

    Reason

    Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes

    Action

    Maquet issued letters to customers on March 20, 2019 via FedEx Standard Overnight states issue, health risk and action to take: remove product and contact Getinge Customer Service at 1-888-627-8383 (press option 2, then option 3) to request a return authorization (RMA) and shipping instructions to return any affected product. Questions please contact your Getinge representative or call the Getinge Customer Support at 1-888-627-8383 (press option 2, then option 3), Monday through Friday from 6:00 a.m. and 5:00 p.m. PST.

    Distribution

    Worldwide distribution - US nationwide in the states of FL, NC and countries of AT, FR, HC, PO.

    Quantity

    17 boxes (5 catheters per box)