Z-0763-2023Class II

Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis

Name: Z-0763-2023 Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis
Creator: Baxter Healthcare Corporation
Published: 2022-11-23
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2022-11-23 / Open, Classified / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis on 2022-11-23. FDA classified it as Class II and gives the reason as "Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0763-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-23
Posted: 2022-12-22
Recalling firm: Baxter Healthcare Corporation
Product: Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
Root cause tag: manufacturing process
FDA 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 in commerce: 6,338,280 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0763-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0762-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-22
Z-0763-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-22
Z-0764-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-22

Product code KDI

K130039Class IIRevaclear 300 Dialyzer, Revaclear 400 DialyzerGambro Renal Products, Inc. / cleared 2013-05-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)