Reported Nov 27, 2019 · Terminated

Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The…

Cincinnati Sub-Zero Products LLC, a Gentherm Company

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cincinnati Sub-Zero Products LLC, a Gentherm Company · 12011 Mosteller Rd · Cincinnati, OH · 45241-1528

Is this the product you have?

  • Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature
  • management Model 233 - Product UsageThe system is composed of a heater, a compressor, a circulating pump and blankets/pads
Lot codes and dates
  • Serial Numbers071-3-00123 through193-3-09498
Amount recalled
3932

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 22, 2020 · Data as of Sep 19, 6:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.