CLASS II ONGOING Device recall · Reported 23 Oct 2024 · FDA Enforcement Report
McKesson Cardiology Hemo recalled by Change Healthcare Canada
Change Healthcare Canada is recalling McKesson Cardiology Hemo, distributed nationwide in the US. The recall was initiated on 21 Aug 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0128-2025
- FDA event ID
- 95284
- Recalling firm
- Change Healthcare Canada, Richmond
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Aug 2024
- FDA classified
- 17 Oct 2024
- Reported
- 23 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 21 Aug 2024 | Recall initiated by company | |
| 17 Oct 2024 | Classified by FDA | +57 days |
| 23 Oct 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when the unit of measurement (UOM) for hemoglobin is configured in a way that differs from the users understanding.
Product as listed by the FDA
McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Ireland, Israel, United Kingdom.
Questions about this recall
Why was it recalled?
A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when the unit of measurement (UOM) for hemoglobin is configured in a way that differs from the users understanding.
Which lots are affected?
UDI Numbers: (01)80010939050010(10)130201, (01)80010939050027(10)140000. Versions Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Ireland, Israel, United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 95284This product is part of a recall event; the main page for the event is Horizon Cardiology Hemo recalled by Change Healthcare Canada.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Horizon Cardiology Hemo recalled by Change Healthcare Canada | Change Healthcare Canada | Labeling Errors | Nationwide | |
| CLASS II | Change Healthcare Cardiology Hemo recalled | Change Healthcare Canada | Labeling Errors | Nationwide |
More recalls from Change Healthcare Canada
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Change Healthcare Radiology Solutions recalled | Change Healthcare Canada | Device Malfunction | Nationwide |
| Device | CLASS II | Change Healthcare Cardiology Hemo recalled | Change Healthcare Canada | Device Malfunction | Nationwide |
| Device | CLASS II | Change Healthcare Cardiology Hemodynamics recalled | Change Healthcare Canada | Device Malfunction | Nationwide |
| Device | CLASS II | Change Healthcare Cardiology Hemo recalled | Change Healthcare Canada | Labeling Errors | Nationwide |
| Device | CLASS II | Horizon Cardiology Hemo recalled by Change Healthcare Canada | Change Healthcare Canada | Labeling Errors | Nationwide |
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| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |