Recall Z-0395-2018— Measurement Specialties Inc

Name: FDA recall Z-0395-2018
Creator: U.S. Food and Drug Administration
Published: 2017-03-13

Class II · Ongoing

Class II FDA medical device recall by Measurement Specialties Inc, initiated 2017-03-13. It names one FDA 510(k) clearance: K962070. 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: The reusable temperature probes are provided with instructions for sterilization that have not been proven through a validation study..

Recalling firm: Measurement Specialties Inc
Classification: Class II
Status: Ongoing
Initiated: 2017-03-13
Firm location: Andover, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K962070 — YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBEYellow Springs Instrument Co., Inc.·cleared 1996-07-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.