TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
Reported: September 3, 2025 Initiated: July 28, 2025 #Z-2439-2025
Product Description
TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
Reason for Recall
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
Details
- Recalling Firm
- VANTIVE US HEALTHCARE LLC
- Units Affected
- 7432 units
- Distribution
- Worldwide
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631. Recalled by VANTIVE US HEALTHCARE LLC. Units affected: 7432 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 3, 2025. Severity: Moderate. Recall number: Z-2439-2025.
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