BEUDAMED
    FDA Recall Open, Classified

    CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC

    Recall: Z-1347-2023 · Initiated March 1, 2023

    Recall

    Recall Number
    Z-1347-2023
    Event Number
    91775
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    3000204839
    Product Code
    DTZ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    March 1, 2023
    Posted
    April 5, 2023
    Address
    125 Blue Ball Rd, Elkton, MD, 21921-5315

    Description

    CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC

    Reason

    Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port.

    Action

    An URGENT MEDICAL DEVICE RECALL notification letter dated 3/1/23 was sent to customers. RECOMMENDED ACTIONS Terumo CVS advises users to remove all affected product from inventory and return unused product to Terumo CVS following the instructions provided in this notice. Terumo CVS will credit the user s accounts for returned, unused products. AFFECTED POPULATION The affected population is all patients on which an impacted Capiox NX, RX or FX Oxygenator is used. CUSTOMER INSTRUCTIONS - Review this Medical Device Recall notice and ensure that all users receive notice of this issue. Refer to the Customer Response Form to identify your product inventory that is subject to this action. Confirm receipt of this communication by completing and returning the attached Customer Response Form to the email address or fax number indicated on the form. Please return the Customer Response Form even if you no longer have the affected product in inventory. If the affected product has been distributed to another user or location, please forward a copy of the notice as needed. Terumo CVS will issue a Return Goods Authorization upon receipt of the Customer Response Form. Return all affected products to Terumo CVS. QUESTIONS? We encourage you to contact Terumo CVS with any questions or concerns: Terumo CVS Customer Service: 1.800.521.2818 Monday Friday, 8 a.m. 6 p.m. ET Terumo Recall Fax: 443-993-5738 or emailing [email protected] Terumo Recall Email: [email protected]

    Distribution

    US Nationwide. Belgium, Canada, Costa Rica, Thailand.

    Quantity

    4940 units