Recall Z-1909-2019 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Corporation
REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
| Date | May 31, 2019 |
| Status | Terminated |
| Reason | There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment. |
| Root cause | Process control |
| Action | The firm, Baxter, sent an " Urgent Product Recall" letter on 05/31/2019. The notice described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Locate and remove all affected product lots from your facility. The product code and lot number can be found on the individual product or 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 Bax |
| Quantity | 65403 units |
| Distribution | US Nationwide Distribution and Internationally to: Canada and Bermuda. |
| 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 |