RecallDepth

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

Company
3M Company Health Care Business 3M Center
Recall Initiated
October 17, 2017
Terminated
November 3, 2020
Recall Number
Z-0114-2018
Quantity
153 cases (3825 sensors)
Firm Location
Saint Paul, MN

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

CA, MI, IL, MO, MN, GA, and Canada, Switzerland

Lot / Code Info

Lot Numbers: 17230, Exp. 2020 Aug 18; 17233, Exp. 2020 Aug 21; 17234, Exp. 2020 Aug 22; 17241, Exp. 2020 Aug 29

Root Cause

Software design

Action Taken

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.

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