FDA recall Z-0763-2023

Product

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

Reason for recall

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

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.

Key facts

Status

Ongoing

Initiation date

2022-11-23

Report date

2022-12-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0763-2023