Recall Z-0370-2017 ยท KDL Set, Perfusion, Kidney, Disposable
Baxter Healthcare Corp.
GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis.
| Date | Nov 8, 2016 (initiated Oct 12, 2016) |
| Status | Terminated |
| Reason | Potential presence of particulate matter on the blood side of the dialyzer |
| Root cause | Process control |
| Action | Baxter sent an Urgent Product Recall letter dated October 12, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: I. Locate and remove all affected product lots from their facility. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. 3. Complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or scanned email. For questions contact Baxter Product Surveillance at 800-437-5176. |
| Quantity | 22,656 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Canada and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060195 | GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE Gambro Renal Products, Apr 24, 2006 |