FDA Recall
Terminated
3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
Recall: Z-0114-2018
·
Initiated October 17, 2017
Recall
- Recall Number
- Z-0114-2018
- Event Number
- 78327
- Firm
- 3M Company Health Care Business 3m Center
- FEI Number
- 2110898
- Product Code
- FLL
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- October 17, 2017
- Terminated
- November 3, 2020
- Address
- 2510 Conway Ave, B # 275-5-W-6, Saint Paul, MN, 55144-0001
Description
3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
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.
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.
Distribution
CA, MI, IL, MO, MN, GA, and Canada, Switzerland
Quantity
153 cases (3825 sensors)