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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78327

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
October 17, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
3M Company - Health Care Business

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0114-2018
Recall number
Z-0114-2018
Initiated
October 17, 2017
Classification
Class II
Status
Terminated
Quantity
153 cases (3825 sensors)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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