BEUDAMED
    FDA Enforcement Class II Ongoing

    Heron toilet and bath chair Model 880505-01 & 880505-11

    Recall: Z-0441-2019 · Reported November 21, 2018

    Enforcement

    Recall Number
    Z-0441-2019
    Event ID
    81217
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    R82 A/S
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 21, 2018
    Initiation Date
    June 30, 2017
    Classification Date
    November 9, 2018
    Address
    Parallelvej 3, Gedved, N/A, Denmark

    Description

    Heron toilet and bath chair Model 880505-01 & 880505-11

    Reason

    Replacement campaign on all units that have a gas spring head in aluminum.

    Code Info

    Serial Numbers: 309658, 310007, 319209, 319822, 319823, 319824, 319825, 319826, 319827, 319829, 319830, 319831, 330695, 330696, 330697, 331862, 331914, 332387, 332586, 332587, 332589, 333755, 333761, 333762, 334833, 342515, 342518, 342523, 345084, 345085

    Distribution

    Nationwide Denmark, Germany, Spain, Finland, France, Great Britain, Island, Netherlands, Norway, Poland, Switzerland, Japan, Australia and New Zealand

    Quantity

    687