Z-0114-2018Class II

3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)

Name: Z-0114-2018 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
Creator: 3M Company - Health Care Business
Published: 2017-10-17
License: https://open.fda.gov/license/

3M Company / initiated 2017-10-17 / Terminated / root cause: software

FDA source

3M Company - Health Care Business began a recall of 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000) on 2017-10-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0114-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-17
Posted: 2017-11-18
Terminated: 2020-11-03
Recalling firm: 3M Company
Product: 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
Product code: FLL Continuous Measurement Thermometer
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 153 cases (3825 sensors)
Distribution: CA, MI, IL, MO, MN, GA, and Canada, Switzerland
Product codes and lots: Lot Numbers: 17230, Exp. 2020 Aug 18; 17233, Exp. 2020 Aug 21; 17234, Exp. 2020 Aug 22; 17241, Exp. 2020 Aug 29

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0114-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0114-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-18

Product code FLL

K120412Class II3M Spoton Temperature Monitoring SystemArizant Healthcare, Inc. / cleared 2012-05-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)