Reported Sep 3, 2025 · Ongoing
TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
Vantive US Healthcare LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: VANTIVE US HEALTHCARE LLC · 510 Lake Cook Rd · Deerfield, IL · 60015-4964
Is this the product you have?
- TherMax Blood Warmer Unit-US, PrisMax Accessory
- Product Codes
955630955515955702955631
- Lot codes and dates
- UDI 07332414124731, All serial numbers
- Amount recalled
- 7432 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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