Recall Z-0739-04 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Asahi Medical Co Ltd
Asahi APS Series Dialyzers, Model Nos. APS-400S, APS-550S, APS-650S, APS-750S, APS-900S, APS-1050S; the dialyzers are intended for single or initial use and under reprocessing and reuse conditions fo rup to 15 reuse cycles; Manufacturer: Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Distributed in teh USA by Nextron Medical, 45 Kulick Road, Fairfield, NJ 0700
| Date | Jul 20, 2004 (initiated Oct 1, 2001) |
| Status | Terminated |
| Reason | Customer reprocessing methods for the reuseable hollow fiber dialyzers may damage the hollow fibers and result in blood leaks during dialysis. |
| Root cause | Other |
| Action | Asahi visited each of the U.S. customers starting on 10/1/01, observing how the facility handles the dialyzer before pre-cleaning, during pre-cleaning and priming. The users were retrained in the reprocessing steps, emphasizing the controls and care to be taken during pre-cleaning, including the verification of water pressure. |
| Quantity | 180,000 units estimated |
| Distribution | New Jersey, Ohio, Texas, California, Georgia, Pennsylvania, Illinois and Indiana |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001250 | APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) Asahi Medical Co., Ltd., Aug 16, 2000 |