Blood warmer units recalled because system may not detect inserted bag
TherMax Blood Warmer Units, an accessory to the PrisMax system, are recalled because the system may be unable to detect a bag on the unit, causing setup difficulty or alarm T2284. 7,432 units are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers precautionary recalls; the stated consequence is difficulty setting up therapy and an alarm, with no patient harm described.
Plain-English summary
The TherMax Blood Warmer Unit-US, a PrisMax accessory, product codes 955630, 955515, 955702 and 955631, UDI 07332414124731, is being recalled across all serial numbers. The recall covers 7,432 units distributed worldwide.
The TherMax system may be unable to detect the presence of a bag on the TherMax Blood Warmer Unit, leading to difficulty setting up therapy or to the PrisMax System alarm T2284, TherMax Disposable Not Inserted. The FDA classified the action as Class II. The notice does not describe a patient consequence beyond the setup difficulty and alarm.
Dialysis units operating these systems should follow the manufacturer's instructions for handling the alarm and for any corrective action.
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 — Dialysis
- Hazard
- detection-failure
- device-alarm
- blood-warmer
- class-ii
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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