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U.S. Department of Health and Human Services

Class 2 Device Recall Asahi APS Series Dialyzers

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  Class 2 Device Recall Asahi APS Series Dialyzers see related information
Date Initiated by Firm October 01, 2001
Date Posted July 20, 2004
Recall Status1 Terminated 3 on March 24, 2004
Recall Number Z-0739-04
Recall Event ID 28341
510(K)Number K001250  
Product Classification Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
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
Code Information Model Nos. APS-400S, APS-550S, APS-650S, APS-750S, APS-900S, APS-1050S. The recall is no lot specific.
Recalling Firm/
Asahi Medical Co Ltd
1-1 Uchiauwaicho,1-Chome
14 Flr, Imperial Tower Bldg
Chiyoda Ku Japan
For Additional Information Contact Mr. Hiroshi Miyazaki
Manufacturer 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 Determined
Cause 2
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KDI and Original Applicant = ASAHI MEDICAL CO., LTD.