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Measurement Specialties Inc recalls Measurement Specialties Reusable Temperature Probe Autoclavable. Sold as Esophageal/Rectal (Adult), Esophageal/Rectal (
Recalled January 31, 2018 · FDA recall Z-0395-2018 · Measurement Specialties
Hazard
The reusable temperature probes are provided with instructions for sterilization that have not been proven through a validation study. · FDA Class II
Units
6,076 devices total
Sold at
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
Description
The reusable temperature probes are provided with instructions for sterilization that have not been proven through a validation study.
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.
Manufacturer(s)
Measurement Specialties Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →