Recall Z-0768-06 ยท FLL Continuous Measurement Thermometer
Smiths Medical ASD, Inc.
TTS-400J Level1 Tympanic Temperature Sensor with 400 Series Thermistor
| Date | Apr 18, 2006 (initiated Mar 8, 2006) |
| Status | Terminated |
| Reason | Product temperature readings may be 2C higher than the actual temperature |
| Root cause | Other |
| Action | Smiths Medical notified consignees by letter dated 3/8/05. Customers are instructed to complete customer reply notices and return affected products for replacement. |
| Quantity | 400 |
| Distribution | Nationwide, Canada, France, Japan, Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K864195 | SURFACE SKIN TEMP PROBE W/THERMOCOUPLE TYPE T Respiratory Support Products, Inc., Nov 19, 1986 |