Baxter Healthcare Corporation: Medical Device Recall in 2022 - (Recall #: Z-0764-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 23, 2022

Date Posted: December 28, 2022

Recall Number: Z-0764-2023

Event ID: 91223

Reason for Recall:

Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak

Status: Ongoing

Product Quantity: 1,140,096 units

Code Information:

No distribution in the USA. Product Code: 114749M; All lot numbers from C422202401 C422227201

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated