Z-0114-2018 Class II Terminated
FDA device recall Z-0114-2018 was initiated by 3M Company - Health Care Business on October 17, 2017 and is designated Class II. 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 … The recall status is terminated (terminated November 3, 2020). Affected quantity: 153 cases (3825 sensors).
Recall Details
- Product Type
- Devices
- Report Date
- November 29, 2017
- Initiation Date
- October 17, 2017
- Termination Date
- November 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 153 cases (3825 sensors)
Product Description
3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
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 Pattern
CA, MI, IL, MO, MN, GA, and Canada, Switzerland
Code Information
Lot Numbers: 17230, Exp. 2020 Aug 18; 17233, Exp. 2020 Aug 21; 17234, Exp. 2020 Aug 22; 17241, Exp. 2020 Aug 29