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Terminated

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

FDA Recall Z-0114-2018 · Posted None

Recalling Firm3M Company - Health Care Business
Recall StatusTerminated
Product CodeFLL
Date Initiated2017-10-17
Date Terminated2020-11-03
Product Quantity153 cases (3825 sensors)

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K1204123M SPOTON TEMPERATURE MONITORING SYSTEMArizant Healthcare, Inc. · 2012-05-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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