Z-0739-04

Asahi APS Series Dialyzers, Model Nos. APS-400S, APS-550S, APS-650S, APS-750S, APS-900S, APS-1050S; the...

Name: Z-0739-04 Asahi APS Series Dialyzers, Model Nos. APS-400S, APS-550S, APS-650S, APS-750S, APS-900S, APS-1050S; the...
Creator: Asahi Medical Co Ltd
Published: 2001-10-01
License: https://open.fda.gov/license/

Asahi Kasei Medical MT Corp. Oita Works / initiated 2001-10-01 / Terminated

FDA source

Asahi Medical Co Ltd began a recall of 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... on 2001-10-01. The reason FDA records is "Customer reprocessing methods for the reuseable hollow fiber dialyzers may damage the hollow fibers and result in blood leaks during dialysis". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0739-04
Status: Terminated
Initiated: 2001-10-01
Posted: 2004-07-20
Terminated: 2004-03-24
Recalling firm: Asahi Kasei Medical MT Corp. Oita Works
Product: 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
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Customer reprocessing methods for the reuseable hollow fiber dialyzers may damage the hollow fibers and result in blood leaks during dialysis.
FDA 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 in commerce: 180,000 units estimated
Distribution: New Jersey, Ohio, Texas, California, Georgia, Pennsylvania, Illinois and Indiana
Product codes and lots: Model Nos. APS-400S, APS-550S, APS-650S, APS-750S, APS-900S, APS-1050S. The recall is no lot specific.

Product code KDI

K001250Class IIAps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models)Asahi Medical Co., Ltd. / cleared 2000-08-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)