Z-0761-2023Class II

Revaclear 400 Dialyzer

Name: Z-0761-2023 Revaclear 400 Dialyzer
Creator: Baxter Healthcare Corporation
Published: 2022-11-23
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2022-11-23 / Open, Classified

FDA source

Baxter Healthcare Corporation began a recall of Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis on 2022-11-23. FDA classified it as Class II and gives the reason as "Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0761-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-23
Posted: 2022-12-22
Recalling firm: Baxter Healthcare Corporation
Product: Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
FDA root cause: Process change control
Action: Baxter Healthcare sent a notification via USPS first class mail on about 11/23/2022 and to home patients on about 11/29/2022. Consignees were instructed to locate and remove all affected product from your inventory, contact Baxter Healthcare Center for Service to arrange for return and credit, and acknowledge the receipt of the notification by completing a reply form on the customer portal. Note: this letter describes two issues. This recall addresses Internal Blood Leaks being caused by a twisted gasket in the dialyzer. The second issue is linked to reports of Polyurethane Displacement in the dialyzer, which is addressed in a separate recall.
Quantity in commerce: 449,544 units
Distribution: Worldwide distribution. US Nationwide including Guam and St. Thomas USVI; 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, and Trinidad and Tobago.
Product codes and lots: Not distributed in the USA. Product Code: 114749M; Lot Numbers: C422202401, C422202501, C422202601, C422202701, C422202801, C422202901, C422203001, C422203101, C422203201, C422203301, C422203401, C422203501, C422203601, C422203701, C422203801, C422203901, C422204001, C422204101, C422204201, C422204301, C422204401, C422204501, C422204701.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0761-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0760-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-22
Z-0761-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-22

Product code KDI

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)