The Recall Desk

FDA (Devices) recall action 83464

Cincinnati Sub-Zero Products LLC, a Gentherm Company recalled 3 products on 2019-11-27

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2019-11-27
Critical
0
Units
12,949

Why these products were 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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • HighFDA (Devices)··2019-11-27

    Cincinnati Sub-Zero Recalls CoolBlue Hyper-Hypothermia Systems for Tissue Damage Risk

    Cincinnati Sub-Zero is recalling 5,291 CoolBlue Hyper-Hypothermia Systems because extended use above 40°C may cause tissue damage. Warning labels have been updated.

    Product
    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-11-27

    Cincinnati Sub-Zero Blanketrol III Hyper-Hypothermia System Recall for Warning Updates

    Cincinnati Sub-Zero is recalling 3,932 Blanketrol III Hyper-Hypothermia Systems to add warnings about tissue damage from extended high temperatures and clarify automatic mode usage.

    Product
    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.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-11-27

    Cincinnati Sub-Zero Recalls Blanketrol II Hyper-Hypothermia Systems

    Cincinnati Sub-Zero is recalling 3,726 Blanketrol II Hyper-Hypothermia Systems to add warnings about potential tissue damage from extended high temperatures.

    Product
    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.
    Category
    Distribution
    0 states