3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
This recall has been terminated (originally issued October 17, 2017).
- Recall Initiated
- October 17, 2017
- Terminated
- November 3, 2020
- Recall Number
- Z-0114-2018
- Quantity
- 153 cases (3825 sensors)
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
CA, MI, IL, MO, MN, GA, and Canada, Switzerland
Lot / Code Info
Lot Numbers: 17230, Exp. 2020 Aug 18; 17233, Exp. 2020 Aug 21; 17234, Exp. 2020 Aug 22; 17241, Exp. 2020 Aug 29
Root Cause
Software design
Action Taken
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.