Events

Recall of Device Recall Measurement Specialties Reusable Temperature Probe Autoclavable

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Measurement Specialties Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78036
  • Event Risk Class
    Class 2
  • Event Number
    Z-0395-2018
  • Event Initiated Date
    2017-03-13
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158538
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Thermometer, electronic, clinical - Product Code FLL
  • Reason
    The reusable temperature probes are provided with instructions for sterilization that have not been proven through a validation study.
  • Action
    Customers were notified via mail or email on March 13, 2017. Additional customers were later identified and notified on June 14, 2017. Instructions included to disregard the sterilization instructions listed in the IFU (A08411F)originally provided with probes and instead utilize the updated IFU 08411G which contains validated sterilization instructions. They were also instructed to forward the recall notification to within their firm and to all organizations if further distributed. For further questions, please call (763) 316-4075.

Device

Device Recall Measurement Specialties Reusable Temperature Probe Autoclavable
  • Model / Serial
    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)
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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
  • Product 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.
  • Manufacturer
    Measurement Specialties Inc

Manufacturer

Measurement Specialties Inc
  • Manufacturer Address
    Measurement Specialties Inc, 1711 139th Ln NW, Andover MN 55304-3926
  • Source
    USFDA