3M Bair Hugger(TM) Normothermia System recall
3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
Why was 3M Bair Hugger(TM) Normothermia System recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 17230, Exp. 2020 Aug 18; 17233, Exp. 2020 Aug 21; 17234, Exp. 2020 Aug 22; 17241, Exp. 2020 Aug 29
- Product
- 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
- Recalling firm
- 3M Company - Health Care Business
- Quantity
- 153 cases (3825 sensors)
- Distribution
- CA, MI, IL, MO, MN, GA, and Canada, Switzerland
- Recall date
- November 29, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)