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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83464

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 02, 2019
Product types
Device
Classifications
Class II
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

3 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 3

Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

Z-0417-2020
Recall number
Z-0417-2020
Initiated
July 02, 2019
Classification
Class II
Status
Terminated
Quantity
3932

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes

Code information

Serial Numbers: 071-3-00123 through193-3-09498

Distribution pattern

Worldwide distribution - US Nationwide and countries of Afghanistan, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Belgium, Bhutan, Brazil, Brunei, Canada Chile, China, Colombia, Costa Rica, Ecuador, Egypt, El Salvador, France, Germany, Guatemala, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Nepal, Netherlands, New Zealand, Oman, Pakistan, Palestine, Panama, Philippines, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, Venezuela, Vietnam.

device · product 2 of 3

Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

Z-0418-2020
Recall number
Z-0418-2020
Initiated
July 02, 2019
Classification
Class II
Status
Terminated
Quantity
3726

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes

Code information

Model 222R (071-18490 through 123-20534) Model 222S (104-2-00001 through 161-2-01848)

Distribution pattern

Worldwide distribution - US Nationwide and countries of Afghanistan, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Belgium, Bhutan, Brazil, Brunei, Canada Chile, China, Colombia, Costa Rica, Ecuador, Egypt, El Salvador, France, Germany, Guatemala, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Nepal, Netherlands, New Zealand, Oman, Pakistan, Palestine, Panama, Philippines, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, Venezuela, Vietnam.

device · product 3 of 3

CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

Z-0419-2020
Recall number
Z-0419-2020
Initiated
July 02, 2019
Classification
Class II
Status
Terminated
Quantity
5291

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes

Code information

Serial Numbers: 073-CB-00001 through 162-CB-00294

Distribution pattern

Worldwide distribution - US Nationwide and countries of Afghanistan, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Belgium, Bhutan, Brazil, Brunei, Canada Chile, China, Colombia, Costa Rica, Ecuador, Egypt, El Salvador, France, Germany, Guatemala, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Nepal, Netherlands, New Zealand, Oman, Pakistan, Palestine, Panama, Philippines, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, Venezuela, Vietnam.