FDAFDA · Food and drugs·Recall number Z-0114-2018
3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
Published November 29, 2017 · Recall initiated: October 17, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- 3M Company - Health Care Business
- Distributor
- CA, MI, IL, MO, MN, GA, and Canada, Switzerland
- Lot
- Lot Numbers: 17230, Exp. 2020 Aug 18; 17233, Exp. 2020 Aug 21; 17234, Exp. 2020 Aug 22; 17241, Exp. 2020 Aug 29
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.