BEUDAMED
    FDA Recall Terminated

    ADVANSYS MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 181032S, 181033S, 181021S, 181022S & 181023S

    Recall: Z-2445-2018 · Initiated May 22, 2018

    Recall

    Recall Number
    Z-2445-2018
    Event Number
    80312
    Firm
    NewDeal SA Immeuble Sequoia
    FEI Number
    3002952164
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    May 22, 2018
    Posted
    July 16, 2018
    Terminated
    November 4, 2019
    Address
    Allee Alexandre Borodineimmeuble Sequoia 2 97 Allee Alexandre Borodine St Priest France 2 97 A 97

    Description

    ADVANSYS MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 181032S, 181033S, 181021S, 181022S & 181023S

    Reason

    Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.

    Action

    On May 22, 2018 Newdeal SAS, a company of Integra LifeSciences, issued URGENT VOLUNTARY MEDICAL DEVICE RECALL notices to their customers. On October 22, 2018 URGENT VOLUNTARY MEDICAL DEVICE RECALL notices were issued to additional customers. Customers were advised to take the following actions: 1. Examine your inventory to determine if you have any affected lots in original product packaging identified within the notice. 2. If you do have any of the affected lots in original product packaging, stop using the product immediately, remove them from service and place in quarantine until the product can be returned. 3. Complete the Acknowledgement and Return Form and check the box: I do have affected products on the list and record the lot number. 4. Or, complete the attached Acknowledgement and Return Form and check the box: I do not have affected products. 5. Complete the other information on the form as indicated on the form. Keep a copy of the form for your records. Return the completed Acknowledgement and Return Form by email or fax indicating your receipt and review of the notification. Customers with questions regarding the instructions, please contact Customer Service at 1-800-654-2873 Monday to Friday 8:00 AM 8:00 PM EST or [email protected] .

    Distribution

    CA, CO, CT, ID, KS, MA, MD, MN, MO, MS, NC, NY, OH, OR, PA, SD, VA, WA & WI