Recall Z-0764-2023 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Corporation
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
| Date | Dec 22, 2022 (initiated Nov 23, 2022) |
| Status | Open, Classified |
| Reason | Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak |
| Root cause | Process control |
| Action | 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 |
| Quantity | 1,140,096 units |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130039 | REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER Gambro Renal Products, Inc., May 2, 2013 |