BEUDAMED
    FDA Enforcement Class II Terminated

    Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature

    Recall: Z-0407-2013 · Reported November 28, 2012

    Enforcement

    Recall Number
    Z-0407-2013
    Event ID
    63532
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vital Signs Colorado Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 28, 2012
    Initiation Date
    August 17, 2012
    Classification Date
    November 20, 2012
    Termination Date
    June 14, 2013
    Address
    11039 East Lansing Circle, N/A, Englewood, CO, 80112-5909, United States

    Description

    Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature

    Reason

    There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe.

    Code Info

    Model Numbers 1016, 1016EU, R1016ES; GXXXX64 All units Made in Costa Rica are affected Lot Numbers: 12089A 12131A 5575A 5586X 5633U 5664E 5685G 5712T 12090B 12138A 5578K 5603R 5636Y 5666R 5685H 5714Z 12100A 12157B 5578L 5606U 5638P 5668N 5685J 12101B 12173A 5580Y 5614N 5638Q 5669G 5689Y 12102A 5573Q 5580Z 5615N 5648T 5669H 5691T 12108B 5574A 5581A 5621U 5648U 5671D 5692H 12109B 5574B 5581L 5623H 5653Z 5673V 5696Q 12114B 5574X 5583E 5631C 5658D 5683V 5700J 12117B 5574Y 5584C 5632V 5660C 5683W 5703N 12130B 5574Z 5584D 5633T 5664D 5683X 5708R

    Distribution

    Worldwide distribution: USA (nationwide) including states of: AR, CA, FL,GA, IL, LA, MA, MI, MO, NC, NH, NY, OH, OK, PA, RI, SE,TX, and WA; and countries of: AUSTRALIA, BARCELONA, GERMANY, NEW ZEALAND, NETHERLANDS, SWITZERLAND, and UNITED KINGDOM.

    Quantity

    243,685 units