Device Recall Asahi APS Series Dialyzers

Model Nos. APS-400S, APS-550S, APS-650S, APS-750S, APS-900S, APS-1050S. The recall is no lot specific.

Gastroenterology-Urology Devices

2

No

New Jersey, Ohio, Texas, California, Georgia, Pennsylvania, Illinois and Indiana

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 07004 USA