Baxter Healthcare Corporation: Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.

Hazard

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

Details from the source

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. Quantity: 6,338,280 units Lot/code info: 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

UPC codes

07332414124076, 07332414126209

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.