FDAClass IIOctober 10, 2018

Hemotherm 400CE recall

Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the…

Why was Hemotherm 400CE recalled?

Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI 10613031860221

Product
Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the…
Recalling firm
Cincinnati Sub-Zero Products LLC, a Gentherm Company
Quantity
270 units
Distribution
US Nationwide Distribution
Recall date
October 10, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls