Z-0174-2007

Asahi AM-BIO D Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of...

Name: Z-0174-2007 Asahi AM-BIO D Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of...
Creator: Asahi Medical Co., Ltd
Published: 2006-10-12
License: https://open.fda.gov/license/

Asahi Kasei Medical MT Corp. Oita Works / initiated 2006-10-12 / Terminated

FDA source

Asahi Medical Co., Ltd began a recall of Asahi AM-BIO D Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted... on 2006-10-12. The reason FDA records is "There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple Use Dialyzers at the end of treatment, possibly damaging the dialyzer nozzle". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0174-2007
Status: Terminated
Initiated: 2006-10-12
Posted: 2006-11-14
Terminated: 2007-11-28
Recalling firm: Asahi Kasei Medical MT Corp. Oita Works
Product: Asahi AM-BIO D Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene butadiene block polymer, 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 AM-BIO-75D - 1.5 m2 surface area and Model AM-BIO-100D - 2.0 m2 surface area
Product code: MSE Hemodialyzer, Re-Use, Low Flux
Reason for recall: There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple Use Dialyzers at the end of treatment, possibly damaging the dialyzer nozzle.
FDA root cause: Other
Action: Asahi sent Safety Alert letters on 10/12/06 to their re-use dialyzer customers advising them of the reports of difficulty separating the blood set from the dialyzer and not to use the Gambro Cartridge Blood Set with Asahi Reuse/Multiple Use Dialyzers in a reuse situation. Enclosed were copies of the temporary revision Instructions For Use with the following warning added at the top of the page: 'Additional Warning for Reuse/Multiple Use Dialyzers: Ashai Reuse/Multiple use dialyzers must not be used in connection with the Gambro cartridge Blood Set in a reuse environment.' Any questions were directed to Karen Borling, RN at 847-498-8500.
Quantity in commerce: 100,000 for all models
Distribution: Nationwide
Product codes and lots: Model AM-BIO-75D and Model AM-BIO-100D, all lots

Product code MSE

K983720Class IIAsahi Am-Bio Series Dialyzers (Wet Models)& (Dry Models), Models Am-Bio-50,Am-Bio-65, Am-Bio-75, and Am-Bio-100, Am-Bio-Asahi Medical Co., Ltd. / cleared 1999-05-17

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)