Vantive US Healthcare recalls TherMax Blood Warmer Units with specific product codes due to potential failure to detect blood bags, risking therapy setup issues.
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
Vantive US Healthcare is recalling TherMax Blood Warmer Units and PrisMax Accessories with product codes 955630, 955515, 955702, and 955631. The recall is because the system may not detect a blood bag, causing setup difficulties or alarms indicating a missing disposable.
The TherMax system may not detect a blood bag during therapy setup, leading to incorrect therapy settings or alarms indicating a missing disposable. This could cause delays or errors in blood transfusion procedures.
Healthcare facilities using TherMax Blood Warmer Units with the listed product codes are affected. Patients receiving blood transfusions through these units are at risk if the system fails to detect the blood bag.
Check for product codes 955630, 955515, 955702, or 955631 on the TherMax Blood Warmer Unit or PrisMax Accessory. All units with the unique device identifier (UDI) 07332414124731 are also affected.
Verify if your TherMax Blood Warmer Unit has product codes 955630, 955515, 955702, or 955631.
Ensure the unique device identifier (UDI) 07332414124731 matches your unit.
The TherMax system may fail to detect a blood bag, causing setup difficulties or alarms indicating a missing disposable.
The recall record does not specify a remedy, so no action is required beyond checking product codes and UDI numbers.
The hazard involves potential setup errors or alarms, but the recall indicates low risk as it does not mention serious injury or death.
We’ve drafted a message you can send Vantive US Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2439-2025 — Vantive US Healthcare Vantive US Healthcare Hello, I own a Vantive US Healthcare that is covered by recall Z-2439-2025 from Vantive US Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
