Z-2439-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 3, 2025
- Initiation Date
- July 28, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7432 units
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
Distribution Pattern
Worldwide
Code Information
UDI 07332414124731, All serial numbers