Revaclear 400 dialyzers recallZ-0763-2023 · Baxter Healthcare Corporation · initiated Nov 23, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
FDA root cause category: Process control
What the company is doing
Baxter Healthcare notified healthcare facilities on 11/23/2022 and home patients on 11/29/2022, via first class mail. Consignees were instructed to be aware of the difference in appearances between Polyurethane Displacement and an Internal Blood Leak and ensure staff is also aware. Additionally, consignees were instructed that if there is a blood leak alarm, to follow your clinical practice to stop treatment, and if only the Polyurethane Displacement is observed, to continue use of the dialyzer. Consignees were asked to acknowledge receipt of the notification by completing and returning the response form.
Recall details
- Recall number
- Z-0763-2023
- Status
- Open, Classified
- Initiated by the company
- Nov 23, 2022
- Posted by the FDA
- Dec 22, 2022
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 6,338,280 units
- Product code
- KDI
- FDA submissions
- K130039
- Distribution
- 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.
Product description
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Code information (models, lots, serial numbers)
a. UDI-DI: 07332414124076; Product Code: 114746L; All lot numbers from C421221401-C422228501. b. UDI-DI: 07332414126209; Product Code: 114746M; All lot numbers from C422218601-C422219901
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- REVACLEAR 400Gambro Renal Products, Inc. · Dialyzer, high permeability with or without sealed dialysate system3 recalls1 death44 reports
- REVACLEAR Revaclear 400Gambro Dialysatoren GmbH · Dialyzer, high permeability with or without sealed dialysate system1 recall1 report
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 91223).
- Z-0762-2023 · Open, ClassifiedRevaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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