TherMax Blood Warmer Unit may fail to detect blood bags correctly
The TherMax Blood Warmer Unit may not detect when a blood bag is present, making it difficult to set up therapy. Approximately 7,432 units are affected, distributed worldwide.
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: FDA Class II medical device used in critical care applications. The sensor detection failure could delay urgent therapy setup in transfusion scenarios. While no injuries have been reported, this qualifies as a risk-of-harm product where injury has not yet been reported, per the severity rubric.
Plain-English summary
VANTIVE US HEALTHCARE LLC is recalling the TherMax Blood Warmer Unit-US and PrisMax Accessory with Product Codes 955630, 955515, 955702, and 955631 due to a bag detection failure.
The device may be unable to detect when a blood bag is properly positioned, which can make it difficult to set up therapy. Additionally, the system may incorrectly trigger the PrisMax System alarm T2284, displaying "Thermax Disposable Not Inserted" even when the disposable has been properly inserted. These issues could cause delays in therapy setup or confusion about device function.
Approximately 7,432 units with UDI 07332414124731 and all serial numbers are included in this recall. The devices were distributed worldwide.
If you use this device, contact VANTIVE US HEALTHCARE LLC for further instructions. Verify proper setup procedures before each use, and report any detection failures or unexpected alarms to the manufacturer.
The recalled product
- Product
- TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
- Manufacturer
- VANTIVE US HEALTHCARE LLC
- Category
- Medical Device — Blood Warmer
- Hazard
- detection-failure
- false-alarm
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 (2)
- UDI 07332414124731
- All serial numbers
Distribution
Distribution scope not specified by the agency.
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