The Recall Desk
HighFDA (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.

What this means for you

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

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.

Related recalls

Same category