Hemotherm Model 400CE Dual Reservoir Coolers/Heaters (serials 151-10283CE to 171-10721CE) may have fuse clips that stretch after a 2017 field action, causing overheating. Recall details and action steps provided.
Evidence supports that when customers performed a fuse replacement as part of a March 2017 field action, the fuse clips became stretched and were no longer mechanically tight with the fuse, creating a host spot that led to discoloration on the board due to overheating and shut down of the device.
Hemotherm's Model 400CE Dual Reservoir Cooler/Heater units (serial numbers 151-10283CE to 171-10721CE) were recalled because fuse clips can stretch after a 2017 field action, leading to overheating and device shutdown. This could affect patients during cardiopulmonary bypass surgery.
After a March 2017 field action where customers replaced fuses, the fuse clips became stretched and no longer securely attached. This created a hotspot that caused overheating and shut down of the device, potentially disrupting blood temperature control during surgery.
Medical professionals using the device during cardiopulmonary bypass procedures for six hours or less. Patients receiving blood temperature management via this device are at risk if the unit fails during surgery.
The Hemotherm Model 400CE Dual Reservoir Cooler/Heater with serial numbers from 151-10283CE to 171-10721CE. The device is used during cardiopulmonary bypass procedures lasting six hours or less.
Identify the serial number on the device to confirm if it falls within the range 151-10283CE to 171-10721CE.
Reach out to Cincinnati Sub-Zero Products LLC for further instructions on the recall.
The recall was issued because fuse clips became stretched after a March 2017 field action, creating a hotspot that caused overheating and device shutdown.
The device may shut down during surgery due to overheating, potentially disrupting blood temperature control for patients undergoing cardiopulmonary bypass procedures.
Check the serial number on the device; affected units have serial numbers from 151-10283CE to 171-10721CE.
We’ve drafted a message you can send Hemotherm to request your refund or repair — edit it as you like.
Subject: Recall Z-0825-2019 — Hemotherm Hemotherm Hello, I own a Hemotherm that is covered by recall Z-0825-2019 from Hemotherm. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
