BEUDAMED
    FDA Enforcement Class II Terminated

    Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.

    Recall: Z-1743-2017 · Reported April 12, 2017

    Enforcement

    Recall Number
    Z-1743-2017
    Event ID
    76606
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 12, 2017
    Initiation Date
    March 3, 2017
    Classification Date
    April 6, 2017
    Termination Date
    October 7, 2019
    Address
    60 Middletown Ave, N/A, North Haven, CT, 06473-3908, United States

    Description

    Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.

    Reason

    Product sterility is compromised due to breach of sterile barrier

    Code Info

    Lot Number beginning with: 14, 15, 16 Expiration Date: From February 2017 through November 2019

    Distribution

    Worldwide Distribution. US (Nationwide), Internationally to Canada, Australia, Brunei, Japan, Mexico, Philippines, Singapore, Andorra, Belgium, Botswana, Czech Republic, Denmark, Egypt, France, Greece, Hungary, Ireland, Israel, Italy, Kenya, Libya, Luxembourg, Mauritius, Namibia, Netherlands, Norway, Poland, Portugal, Russia, Russian Federation, Spain, Saudi Arabia, Seychelles, Slovakia, South Africa, Switzerland, UAE, and United Kingdom.

    Quantity

    38794