Recall Z-1409-2020 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Corporation
Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
| Date | Nov 15, 2019 |
| Status | Terminated |
| Reason | There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer. |
| Root cause | Process control |
| Action | The firm initiated the recall by letter on 11/15/2019. The letter requests the following actions be taken: "1. Locate and remove all affected product lots from your facility. The product code and lot number can be found on the individual product and shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, lot number, and quantity of produ |
| Quantity | 101976 devices |
| Distribution | Nationwide |
| 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 |