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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/
Manufacturer
Asahi Medical Co Ltd
1-1 Uchiauwaicho,1-Chome
14 Flr, Imperial Tower Bldg
Chiyoda Ku Japan
For Additional Information Contact Mr. Hiroshi Miyazaki
847-498-8500
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
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
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.
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