FDAHealthJuly 28, 2025
VANTIVE US HEALTHCARE LLC — TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
⚠️ 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 PrisMax System alarm T2284: Thermax Disposable Not Inserted
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- July 28, 2025
Worldwide
What's affected?
- Product
- TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
- Lot code
- UDI 07332414124731, All serial numbers
Additional details
UDI 07332414124731, All serial numbers
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 7432 units.
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