Z-0790-05

Asahi APS Series Hollow Fiber Dialyzers; a wet model mutiple use dialyzer consisting of hollow fiber...

Name: Z-0790-05 Asahi APS Series Hollow Fiber Dialyzers; a wet model mutiple use dialyzer consisting of hollow fiber...
Creator: Asahi Medical Co Ltd
Published: 2005-03-31
License: https://open.fda.gov/license/

Asahi Kasei Medical MT Corp. Oita Works / initiated 2005-03-31 / Terminated

FDA source

Asahi Medical Co Ltd began a recall of Asahi APS Series Hollow Fiber Dialyzers; a wet model mutiple use dialyzer consisting of hollow fiber membranes of polysulfone housed within a plastic casing of... on 2005-03-31. The reason FDA records is "Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0790-05
Status: Terminated
Initiated: 2005-03-31
Posted: 2005-05-03
Terminated: 2006-07-10
Recalling firm: Asahi Kasei Medical MT Corp. Oita Works
Product: Asahi APS Series Hollow Fiber Dialyzers; a wet model mutiple use dialyzer consisting of hollow fiber membranes of polysulfone housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Model APS-21R - 2.1 m2 surface area
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.
FDA root cause: Other
Action: Asahi sent Henry Schein, Inc. a recall letter dated 3/30/05, requesting the recall of the affected lots of Asahi labeled product, and Henry Schein, Inc. recalled the Asahi labeled dialyzers by letter dated 3/31/05, with a copy of the Asahi 3/30/05 letter. The accounts were informed that the dialyzers may have been exposed to temperature variances during distribution, and werw requested to cease distribution/use of the specific lots listed and return them to Henry Schein for credit. The recall was expanded to include the Terumo labeled dialyzers distributed by Asahi by Henry Schein letter dated 4/13/05, accompanied by a Terumo letter dated 4/8/05, sent to the accounts via first class mail on 4/14/05. The instructions were the same as in the 3/31/05 letter. A revised letter dated 4/21/05 was sent on 4/25/05, correcting the Henry Schein product codes involved in the Terumo labeled product. Any questions were directed Asahi Kasei Medical Co. at 847-498-8500.
Quantity in commerce: 23,979 units
Distribution: Nationwide and Puerto Rico
Product codes and lots: Schein product code 629-4923, Model APS-21R, lot numbers U4383Y, U4383Y8K8N, X46R6V, W4797A, W4797A7X7B, X47X7B, X47X7B7Q7U, W47Q7U, W47Q7U7R7U, W47R7U, W48K8N

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)