BEUDAMED
    FDA Enforcement Class II Ongoing

    Measurement Specialties Reusable Temperature Probe Autoclavable. Sold as Esophageal/Rectal (Adult), Esophageal/Rectal (Pediatric), and Skin (Adult) Intended for use by a licensed physician to continuously monitor human esophageal, rectal, or skin temperature. They are designed to be used with any patient monitoring system designed to accept 400 Series temperature probes.

    Recall: Z-0395-2018 · Reported January 31, 2018

    Enforcement

    Recall Number
    Z-0395-2018
    Event ID
    78036
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Measurement Specialties Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 31, 2018
    Initiation Date
    March 13, 2017
    Classification Date
    January 19, 2018
    Address
    1711 139th Ln NW, N/A, Andover, MN, 55304-3926, United States

    Description

    Measurement Specialties Reusable Temperature Probe Autoclavable. Sold as Esophageal/Rectal (Adult), Esophageal/Rectal (Pediatric), and Skin (Adult) Intended for use by a licensed physician to continuously monitor human esophageal, rectal, or skin temperature. They are designed to be used with any patient monitoring system designed to accept 400 Series temperature probes.

    Reason

    The reusable temperature probes are provided with instructions for sterilization that have not been proven through a validation study.

    Code Info

    Part No. 401AC (Lot No. 14K87246, 15M96863, 13E72645, 12D61386, 13D72302, 16B97593, 15C91286, 13B64377, 14J86547, 12B59416, 13A69334, 15K95972, 15A97196, 15E92377, 15F92378, 13L77336, 12D61023, 14G84704, 14K87499, 14F84193, 13L77335, 16B97594, 15C91419, 13B70167, 15C91448, 15E92375, 15K96046, 16A97197, 12B59529, 16B97798, 15K96125, 16B97595, 15L96777, 12D61829, 13D72644, 15A89998, 13F73449, 12M64134, 15L96745, 15D90215, 15H95035, 13F74403, 13L78489, 13L77336, 12H65961, 14G84878, 12F62179, 14J87014, 12B55182, 14F84444, 14J87081, 13L77336, 13L78489, 14F84400, 12J66632, 16A97380, 12M68130, 15E92376, 14L88737, 14L87904, 12K66633, 13H74994, 13H74995, 12B60056, 12C57285, 14H86266, 16A97592, 14J87164, 12D59168, 14M89765, 12A54328, 15A89854, 14F84634, 14G84624, 15M96829, 15K95896); Part No. 402AC (Lot No. 13E73262, 15E92379, 12E57286, 12L68344, 15E93385, 12H65752, 12H65787, 15F92380, 12J65322, 15F92381, 12K67454, 15A89941, 15A89282, 13H75930, 12F55548, 12K67533, 13H75930, 12J66809, 12B59570, 15E92010, 12A50150, 14E83393); Part No. 409AC (Lot No. 12C56215, 12B56215, 15C90920, 15K28358, 12C60069, 13B70035, 16B97312, 13A69520, 14E83602, 13E73264, 12L68584, 11M57610, 12F59571, 15B90832, 15E92560, 12K63370, 16B97614, 12L54648, 15D92011, 12M63372, 14H85773, 16B97615, 15M97109, 16B97805, 12M69229, 15A89939, 15A90196, 12F60692, 14L88520, 14L88519, 13A70145, 15E92382, 15A90466, 13E73450, 15F92383, 13D72925)

    Distribution

    USA (nationwide) distribution to the states of : AL, CA, KY, IL, KS, MN, NY, OH, TX, VA and WI. Distributed internationally to: Australia, Canada, China, England, Germany, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, Singapore, South Africa, South Korea, Taiwan, Vietnam

    Quantity

    6,076 devices total