Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1924-2018·Announced 2018-05-30

Baxter Prismaflex Control Units Recalled for Pump Module Electronics Failure

Baxter Healthcare is recalling Prismaflex control units 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 classified as FDA Class II. The hazard is a device malfunction that renders the unit inoperable, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Baxter Healthcare Corporation is recalling 2,772 units of the Prismaflex 7.XX ROW control unit (Product Code 114870) to address a potential failure mode in the pump module electronics. The affected units are distributed worldwide, including in the United States, Canada, Australia, and numerous other countries across Asia, the Americas, and Europe.

The identified failure mode may result in a "Voltage Out of Range" malfunction alarm. When this alarm occurs, the device enters a "safe state" and becomes inoperable until it is serviced. This issue affects all lots and serial numbers of the specified product code.

Baxter Healthcare is installing new firmware on all Prismaflex control units 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. Users should contact Baxter Healthcare for information regarding the firmware update.

The recalled product

Product: Prismaflex 7.XX ROW, Product Code 114870 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 — Renal Replacement Therapy
Hazard: device-malfunction
Affected units: 2,772

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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