FDA Medical devices recall ·
TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630… recall
- Recall number
- Z-2439-2025
- Date
- (initiated July 28, 2025)
- Company / brand
- Vantive Us Healthcare LLC
510 Lake Cook Rd, Deerfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 7432 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
Why was it 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
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI 07332414124731, All serial numbers
Distribution
Worldwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2439-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.