Recall Z-0114-2018 ยท FLL Continuous Measurement Thermometer
3M Company - Health Care Business
3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
| Date | Oct 17, 2017 |
| Status | Terminated |
| Reason | During a recent investigation, 3M confirmed that a programming translation error could occur in a small amount of the sensors that could lead to a temperature readout that is lower than the patients actual temperature. |
| Root cause | Software design |
| Action | The firm initiated their recall on 10/17/2017 via mail. International subsidiaries were notified via email, also on October 17, 2017.Distributors were asked to notify their customers and all direct consignees were directed to dispose of the product on site. |
| Quantity | 153 cases (3825 sensors) |
| Distribution | CA, MI, IL, MO, MN, GA, and Canada, Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120412 | 3M SPOTON TEMPERATURE MONITORING SYSTEM Arizant Healthcare, Inc., May 30, 2012 |