FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
- Recall number
- Z-0762-2023
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
- Status
- Open, Classified
- Initiated
- 2022-11-23
- Posted
- 2022-12-22
- Terminated
- not on file
- Reason
- Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
- Root cause
- Process control
- Action
- 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.
- Quantity
- 14,053,824 units
- 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.
- Lot, serial or model codes
- UDI-DI: 07332414123055; Product Code: 114745L; All lot numbers from C419128801-C422128401
- 510(k) numbers
- ["K130039"]
- PMA numbers
- not on file
- Product code
- KDI
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28