Recall Z-0395-2018 ยท FLL Continuous Measurement Thermometer
Measurement Specialties Inc
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.
| Date | Mar 13, 2017 |
| Status | Open, Classified |
| Reason | The reusable temperature probes are provided with instructions for sterilization that have not been proven through a validation study. |
| Root cause | 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962070 | YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE Yellow Springs Instrument Co., Inc., Jul 19, 1996 |