BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2445-2018 · Reported July 25, 2018

    Enforcement

    Recall Number
    Z-2445-2018
    Event ID
    80312
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    NewDeal SA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 25, 2018
    Initiation Date
    May 22, 2018
    Classification Date
    July 16, 2018
    Termination Date
    November 4, 2019
    Address
    Immeuble Sequoia 2 97 A, 97 Allee Alexandre Borodineimmeuble Sequoia 2 97 Allee Alexandre Borodine, St Priest, N/A, France

    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.

    Code Info

    181051S - Lot # FCK9, FG3H & FG3J 181052S - Lot # E8PA/G & EB1H/G 181041S - Lot # F0AS, F0AT & F0AU 181042S - Lot # E8P8/G & EB1F/G 181031S - Lot # E8N2/G, E8NL/G, E8P4/G, E8PS/G, EBKW/G, EBKW/G1 & F8EH 181032S - Lot # E8P5/G, E8P5/G1, E8PT/G, EB1C/G, EBKX/G & F8EJ 181033S - Lot # E8PU/G 181021S - Lot # E8NH/G & E8P1/G-EB18/G 181022S - Lot # E8MF/G, E8MF/G/Q, E8PQ/G & EBKU/G 181023S - Lot # E8MG/G, E8P3/G, E8PR/G & F8EG

    Distribution

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