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Class 2 Device Recall Measurement Specialties Reusable Temperature Probe Autoclavable |
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Date Initiated by Firm |
March 13, 2017 |
Create Date |
January 19, 2018 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0395-2018 |
Recall Event ID |
78036 |
510(K)Number |
K962070
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Product Classification |
Thermometer, electronic, clinical - Product Code FLL
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Product |
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. |
Code Information |
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) |
Recalling Firm/ Manufacturer |
Measurement Specialties Inc 1711 139th Ln NW Andover MN 55304-3926
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For Additional Information Contact |
763-316-4075
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Manufacturer Reason for Recall |
The reusable temperature probes are provided with instructions for sterilization that have not been proven through a validation study.
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FDA Determined Cause 2 |
Other |
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. |
Quantity in Commerce |
6,076 devices total |
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 |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = FLL and Original Applicant = YELLOW SPRINGS INSTRUMENT CO., INC.
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