Baxter Recalls Prismaflex Control Units for Firmware Update
Baxter Healthcare is recalling 557 Prismaflex 7.XX US control units worldwide to install new firmware that prevents a pump module electronics failure.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a device malfunction that causes the unit to enter a safe state and become inoperable, with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Baxter Healthcare Corporation is recalling 557 units of the Prismaflex 7.XX US control unit (Product Code 115269). The device is intended for Continuous Renal Replacement Therapy (CRRT) and Therapeutic Plasma Exchange (TPE) for patients weighing 20 kilograms or more. The recall covers all lots and serial numbers.
The recall is being conducted to address a potential failure mode in the pump module electronics. This issue may cause a "Voltage Out of Range" malfunction alarm, which forces the device into a safe state and renders it inoperable until serviced. Baxter Healthcare is installing new firmware on all affected units to prevent this malfunction from occurring.
The affected units were distributed worldwide, including the United States (including Puerto Rico), Canada, Australia, New Zealand, and various countries in Asia, the Americas, and EMEA. No specific instructions for consumers are provided in the source text, as the recall involves the installation of new firmware by the manufacturer.
The recalled product
- Product
- Prismaflex 7.XX US, Product Code 115269 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) ther
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 557
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots and Serial Numbers
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 5 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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