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.
FDA Recall Z-0395-2018 · Posted None
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Recalling FirmMeasurement Specialties Inc
Recall StatusOpen, Classified
Product CodeFLL
Date Initiated2017-03-13
Product Quantity6,076 devices total
Reason for Recall
The reusable temperature probes are provided with instructions for sterilization that have not been proven through a validation study.
Firm 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.
Root Cause
Other
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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