Exact FDA event identifier

Event 83387

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

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Event summary

Timeline bucket: July 19, 2019
Product types: Device
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Cincinnati Sub-Zero Products LLC, a Gentherm Company

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

MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.

Z-2291-2019

Recall number: Z-2291-2019
Initiated: July 19, 2019
Classification: Class III
Status: Terminated
Recalling firm: Cincinnati Sub-Zero Products LLC, a Gentherm Company
Quantity: 2079 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage

Code information

Serial Numbers 141-LT-02789 through 193-LT-05137 UDI: 10613031881165

Distribution pattern

Nationwide Foreign: AUSTRALIA CANADA CHILE COLOMBIA COLOMBIA GUATEMALA ISRAEL JAPAN NETHERLANDS POLAND SINGAPORE SOUTH KOREA UNITED ARAB EMIRATES