Agency classClass IIOur severity:High FDA (Devices)·Z-0215-2022·Announced 2021-11-17

Hemodialysis Delivery System Software May Use Incorrect Treatment Parameters

Baxter's Hemodialysis Delivery System may incorrectly revert to old prescription values when operators change prescriptions after filter changes, potentially resulting in incorrect treatment parameters.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of software in a critical hemodialysis system. While the potential for incorrect treatment parameters exists due to a logic defect, no illnesses or injuries are documented in the source material. As a risk-of-harm product without reported injury, it receives a High severity rating per the rubric.

Plain-English summary

Baxter Healthcare Corporation is recalling 4,248 units of the Hemodialysis Delivery System, Software Version 2.x. The recall addresses a software logic issue: when an operator initiates therapy using a saved prescription profile and then changes the prescription after a disposable filter change while using the Same Patient button, the system may suggest values from the original prescription profile instead of the current prescription. This could result in dialysis therapy being delivered with therapy parameters that do not reflect the intended prescription.

The affected systems are distributed nationwide across all U.S. states and internationally to multiple countries: Canada, Mexico, Brazil, Australia, Singapore, Hong Kong, Vietnam, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Israel, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, and the United Kingdom.

This is an FDA Class II recall. Baxter Healthcare Corporation has documented the specific product codes, UDIs, and lot/serial numbers affected by this recall.

The recalled product

Product: Hemodialysis Delivery System, Software Version 2.x.
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Hemodialysis System
Hazard: software-logic-error
incorrect-treatment-parameters
Affected units: 4,248

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 (20)

Software Version 2.x.
Product Code: 955626
UDI: 0085412639499 (Lot/Serial #107208
107209
107210
107211
107378
107379
107380
107381
107382
107383
107384
107385
107386
107387
107483
107484
107485
107486

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

Same manufacturer · Baxter Healthcare Corporation

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