BEUDAMED
    FDA Recall Terminated

    Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The device is a component of the MPS Console used as replacements for worn or damaged MPS Console top covers)

    Recall: Z-2107-2020 · Initiated December 17, 2019

    Recall

    Recall Number
    Z-2107-2020
    Event Number
    85389
    Firm
    Quest Medical, Inc.
    FEI Number
    3001665800
    Product Code
    DTR
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 17, 2019
    Terminated
    April 17, 2024
    Address
    1 Allentown Pkwy, Allen, TX, 75002-4206

    Description

    Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The device is a component of the MPS Console used as replacements for worn or damaged MPS Console top covers)

    Reason

    Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or damaged MPS Console Top Covers for cardiopulmonary bypass heat exchanger, used to deliver whole blood to the heart during open heart surgery, were swapped and incorrectly placed. This could lead to over delivery of potassium by the user requiring medical intervention.

    Action

    Customers who received product/affected lot were to be contacted via letter, Urgent-Product Recall Notice, dated 12/6/2019 sent to customers via XXX. Customers were to review their inventory to see if they had products from the affected lot. If they did have these products they were to place the product in quarantine and contact Quest Medical, Inc. using a form included with the recall notification. It instructed customers to complete and return the enclosed response form to Tosan Onosode Regulatory Affairs Supervisor,Quest Medical, Inc.,One Allentown Parkway Allen, TX 75002-4211 USA, Email: [email protected] Fax: +1 469-795-2338, Phone: +1 800-627-0226 ext. 338 so that they can arrange to correct the labeling defect on these units. It further stated that If customers had any questions or concerns regarding this action, they should contact Tosan Onosode, Regulatory Affairs Supervisor, Recall Coordinator at 1-800-627-0226, ext. 338.

    Distribution

    US Nationwide distribution including in the states of NY, PA, TN, WV. OUS: None

    Quantity

    5 units