BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated June 7, 2022

    Recall

    Recall Number
    Z-1304-2022
    Event Number
    90377
    Firm
    Davol, Inc.
    FEI Number
    1213643
    Product Code
    GCJ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 7, 2022
    Address
    100 Crossings Blvd, Warwick, RI, 02886-2850

    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.

    Action

    On June 7, 2022, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were instructed to destroy all affected product remaining in their possession.

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

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