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
FDA Recall Z-0739-04 · Posted 2004-07-20
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Recalling FirmAsahi Medical Co Ltd
Recall StatusTerminated
Product CodeKDI
Date Initiated2001-10-01
Date Terminated2004-03-24
Product Quantity180,000 units estimated
Reason for Recall
Customer reprocessing methods for the reuseable hollow fiber dialyzers may damage the hollow fibers and result in blood leaks during dialysis.
Firm 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.
Root Cause
Other
Distribution Pattern
New Jersey, Ohio, Texas, California, Georgia, Pennsylvania, Illinois and Indiana
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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