BEUDAMED
    FDA Recall Terminated

    Valleylab Laparoscopic Flat L-Hook Electrode Retractable Item Code: E2784R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable

    Recall: Z-2577-2016 · Initiated July 8, 2016

    Recall

    Recall Number
    Z-2577-2016
    Event Number
    74602
    Firm
    Medtronic
    FEI Number
    1219930
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 8, 2016
    Terminated
    August 8, 2018
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908

    Description

    Valleylab Laparoscopic Flat L-Hook Electrode Retractable Item Code: E2784R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable

    Reason

    Potential for compromise of the package resulting in a breach of the sterile barrier

    Action

    Medtronic/Covidien sent an Urgent Medical Device Recall letter dated July 8, 2016, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. The letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Customers with questions were instructed to contact their Medtronic representative or Customer Service at 800-882-5878.

    Distribution

    Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

    Quantity

    3470