CLASS II ONGOING Device recall · Reported 28 Dec 2022 · FDA Enforcement Report
Revaclear 400 dialyzers recalled by Baxter Healthcare
Baxter Healthcare is recalling Revaclear 400 dialyzers, distributed nationwide in the US. The recall was initiated on 23 Nov 2022 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-0764-2023
- FDA event ID
- 91223
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Nov 2022
- FDA classified
- 22 Dec 2022
- Reported
- 28 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 23 Nov 2022 | Recall initiated by company | |
| 22 Dec 2022 | Classified by FDA | +29 days |
| 28 Dec 2022 | 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
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, China, Australia, New Zealand, Austria, Egypt, France, Germany, Ireland, Italy, Morocco, Qatar, Saudi Arabia, South Africa, Spain, United Kingdom, Bahamas, Barbados, Belize, Bermuda, Colombia, Dominican Republic, Ecuador, Guatemala, Honduras, Mexico, Panama, St. Thomas, Trinidad and Tobago.
Questions about this recall
Why was it recalled?
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
Which lots are affected?
No distribution in the USA. Product Code: 114749M; All lot numbers from C422202401 C422227201
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, China, Australia, New Zealand, Austria, Egypt, France, Germany, Ireland, Italy, Morocco, Qatar, Saudi Arabia, South Africa, Spain, United Kingdom, Bahamas, Barbados, Belize, Bermuda, Colombia, Dominican Republic, Ecuador, Guatemala, Honduras, Mexico, Panama, St. Thomas, Trinidad and Tobago.
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 91223This product is part of a recall event; the main page for the event is Revaclear 300 dialyzers recalled by Baxter Healthcare.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Revaclear 300 dialyzers recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide | |
| CLASS II | Revaclear 400 dialyzers recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
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