High FDA (Devices)·Z-1825-2017·Announced 2017-04-26

Cincinnati Sub-Zero Recalls Hemotherm CE Heater-Cooling Devices Due to Fuse Defect

Cincinnati Sub-Zero is recalling 390 Hemotherm CE model 400CE heater-cooling devices because improperly rated fuses were used in their manufacture.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves improperly rated fuses in a medical device, which presents a risk of harm (such as electrical failure or fire) even though no injuries have been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Cincinnati Sub-Zero Products Inc is recalling 390 units of the Hemotherm CE, model 400CE, Heater-Cooling Device. The recall was initiated because improperly rated fuses were used in the manufacture of the devices.

The recalled products were distributed worldwide, including to 26 U.S. states, Mexico, and Taiwan. Specific distribution accounts include Koolfer S.A. DE C.V. in Mexico and WRNMMC -PAA in Bethesda, Maryland. The source text does not specify the exact dates of distribution or the specific lot numbers for each unit, though a list of device codes is provided in the structured data.

Healthcare facilities and consumers who possess these devices should stop using them immediately and contact Cincinnati Sub-Zero Products Inc for instructions on repair or replacement. The source text does not report any illnesses or injuries associated with this defect.

The recalled product

Product: Hemotherm CE, model 400CE, Heater-Cooling Device
Manufacturer: Cincinnati Sub-Zero Products Inc
Category: Medical Device — Heater-Cooling Device
Hazard: electrical-defect
fire-risk
Affected units: 390

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

151-10283CE
151-10284CE
151-10285CE
151-10286CE
151-10287CE
151-10290CE
151-10291CE
151-10292CE
151-10293CE
151-10294CE
151-10295CE
151-10296CE
151-10297CE
151-10298CE
151-10299CE
152-10300CE
152-10301CE
152-10302CE
152-10303CE
152-10304CE

Distribution

Distributed in 25 states:

Same manufacturer · Cincinnati Sub-Zero Products Inc

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Same hazard · electrical defect