BEUDAMED
    FDA Enforcement Class II Ongoing

    Vasc. Open CVOR SJH, REF SJVO56B

    Recall: Z-0177-2024 · Reported November 1, 2023

    Enforcement

    Recall Number
    Z-0177-2024
    Event ID
    93086
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    American Contract Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 1, 2023
    Initiation Date
    September 1, 2023
    Classification Date
    October 26, 2023
    Address
    7802 E Telecom Pkwy, N/A, Temple Terrace, FL, 33637-0928, United States

    Description

    Vasc. Open CVOR SJH, REF SJVO56B

    Reason

    During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.

    Code Info

    UDI/DI 00191072182869, Lot Numbers: 940231, 974231

    Distribution

    US Nationwide distribution in the states of FL, IA.

    Quantity

    84 cases