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U.S. Department of Health and Human Services

Class 2 Device Recall Asahi AMBIO Series Hollow Fiber Dialyzers

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  Class 2 Device Recall Asahi AMBIO Series Hollow Fiber Dialyzers see related information
Date Initiated by Firm March 31, 2005
Date Posted May 03, 2005
Recall Status1 Terminated 3 on July 10, 2006
Recall Number Z-0788-05
Recall Event ID 31536
510(K)Number K983720  
Product Classification Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
Product Asahi AM-BIO Series Hollow Fiber Dialyzers; a wet model multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose 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; Models AM-BIO-65 - 1.3 m2 surface area , AM-BIO-75 - 1.5 m2 surface area and AM-BIO-100 - 2.0 m2 surface area
Code Information Schein product code 629-6426, Model AM-BIO-65, lot numbers 04191H, 044A4T, 0419H4A4T;  Schein product code 629-3146, Model AM-BIO-75, lot numbers 044L54, 046Q73, 044L546Q73; Schein product code 629-0041, Model AM-BIO-100, lot numbers 044J53, 04616X, 04616X626Y, 04626Y, 04626Y636B, 04636B, 04636B696K, 04696K, 046F6Q, 046F6Q6L6S, 046H6S, 046L6S, 046L6S6M6V, 046M6V, 046M6V6P72, 046P72, 046Q73
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		 Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.
FDA Determined
Cause 2		 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 95,129 units
Distribution Nationwide and Puerto Rico
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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