BEUDAMED
    FDA Enforcement Class II Terminated

    Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile P/N: 1024920 Rev. 01 Low temperature smooth interior tubing is a disposable pulmonary equipment interconnect used in ventilation and aesthesia machines.

    Recall: Z-0120-2019 · Reported October 24, 2018

    Enforcement

    Recall Number
    Z-0120-2019
    Event ID
    81076
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    A M Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 24, 2018
    Initiation Date
    August 10, 2018
    Classification Date
    October 16, 2018
    Termination Date
    May 13, 2021
    Address
    131 Business Park Loop, Box 850, Sequim, WA, 98382-8338, United States

    Description

    Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile P/N: 1024920 Rev. 01 Low temperature smooth interior tubing is a disposable pulmonary equipment interconnect used in ventilation and aesthesia machines.

    Reason

    Some of the Disposable Smooth Interior Tubing may pull apart when stretched.

    Code Info

    Product Code: 243301 Lot Numbers: 572015 574717 578973 579100 582567

    Distribution

    US Distribution to states of: OH, PA, and NC.

    Quantity

    610