Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
This recall is currently active, issued December 22, 2022. It was issued by Baxter Healthcare Corporation.
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- November 23, 2022
- Posted
- December 22, 2022
- Recall Number
- Z-0763-2023
- Quantity
- 6,338,280 units
- Firm Location
- Deerfield, IL
- Official Source
- View on FDA website ↗
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.
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
Root Cause
Process control
Action Taken
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.