BEUDAMED
    FDA Enforcement Class II Ongoing

    HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing, Catalog number 0026880

    Recall: Z-1304-2022 · Reported July 6, 2022

    Enforcement

    Recall Number
    Z-1304-2022
    Event ID
    90377
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Davol, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 6, 2022
    Initiation Date
    June 7, 2022
    Classification Date
    June 30, 2022
    Address
    100 Crossings Blvd, Warwick, RI, 02886-2850, United States

    Description

    HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing, Catalog number 0026880

    Reason

    The product is not able to provide irrigation.

    Code Info

    UDI: (01)00801741010224(17)241028(10)JUFX2830 (01)00801741010224(17)241028(10)JUFY0743 Lots JUFX2830 JUFY0743

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    4,780 (4,390 in US, 390 in Canada)