Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1922-2018·Announced 2018-05-30

Baxter Recalls Prismaflex Systems for Pump Module Electronics Failure

Baxter Healthcare is recalling Prismaflex Systems to install new firmware that prevents a pump module electronics failure causing the device to become inoperable.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 a voluntary precautionary measure to prevent a device malfunction that renders the unit inoperable. No injuries, illnesses, or deaths are reported in the source text.

Plain-English summary

Baxter Healthcare Corporation is recalling 5,880 units of the Prismaflex System, Product Code 107493. The recall covers all lots and serial numbers distributed worldwide, including the United States, Canada, Australia, and numerous other countries.

The recall is being conducted to address a potential failure mode in the pump module electronics of a small number of units. This failure may trigger a "Voltage Out of Range" malfunction alarm, causing the device to enter a safe state and become inoperable until it is serviced. Baxter is releasing new firmware to prevent this malfunction from occurring.

The Prismaflex Control Unit is intended for Continuous Renal Replacement Therapy (CRRT) and Therapeutic Plasma Exchange (TPE) for patients weighing 20 kilograms or more. The device is used for patients with acute renal failure, fluid overload, or diseases requiring plasma component removal. All treatments must be prescribed by a physician.

The recalled product

Product: Prismaflex System, Product Code 107493 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)…
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Dialysis Equipment
Hazard: device-malfunction
Affected units: 5,880

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.

See all 5 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · device malfunction