FDA recall Z-0395-2018

Measurement Specialties Inc · Class II · device

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.

Reason for recall

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

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

Key facts

Status
Ongoing
Initiation date
2017-03-13
Report date
2018-01-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Andover, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0395-2018