FDA Device recall Z-0114-2018
3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
- FDA Device
- Class II
- terminated
- Published 2017-11-29
On 2017-11-29 the FDA classified a Class II recall of 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000) by 3m Health Care Business, citing 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 lowe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0114-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-17 |
| Published | 2017-11-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | 3m Health Care Business |
| Distribution | CA, GA, IL, MI, MN, MO |
Product
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.
Identifiers
| code_info | Lot Numbers: 17230, Exp. 2020 Aug 18; 17233, Exp. 2020 Aug 21; 17234, Exp. 2020 Aug 22; 17241, Exp. 2020 Aug 29 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0114-2018%22
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