Recall Z-2424-2012 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Asahi Kasei Medical Co., Ltd., Okatomi Plant
Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter
| Date | Sep 20, 2012 (initiated Sep 21, 2012) |
| Status | Terminated |
| Reason | Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products. |
| Root cause | Process change control |
| Action | AsahiKASEI Medical Co., LTD sent a Medical DeviceRecall letter on September 21, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to confirm that they have no inventory and to forward the letter to all clinics who may have received the product requesting they check their stock and arrange for the return of any recalled product. Non-responding consignees will be contacted by telephone. For questions regarding this recall call Asaki Kasei Medical America, Inc. at 888-362-6105. |
| Quantity | 5184 units |
| Distribution | REXEED SX: Worldwide Distribution - USA including TN and the countries of Japan and Germany REXEED LX: Worldwide Distribution - USA including TN and Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082515 | ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX Asahi Kasei Medical Co., Ltd., Oct 3, 2008 |