FDA Medical Device Recalls (openFDA)
Asahi Medical Co Ltd: Asahi AM-BIO-HX Extended Range Series Hollow Fiber Dialyzers; a wet model single 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-HX-75 - 1.5 m2 surface area and AM-BIO-HX-100 - 2.0 m2 surface area
- Recall number
- Z-0789-05
- Recalling firm
- Asahi Medical Co Ltd
- Product
- Asahi AM-BIO-HX Extended Range Series Hollow Fiber Dialyzers; a wet model single 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-HX-75 - 1.5 m2 surface area and AM-BIO-HX-100 - 2.0 m2 surface area
- Status
- Terminated
- Initiated
- 2005-03-31
- Posted
- 2005-05-03
- Terminated
- 2006-07-10
- Reason
- Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.
- Root cause
- 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
- 38,760 units
- Distribution
- Nationwide and Puerto Rico
- Lot, serial or model codes
- Schein product code 629-6404,Model AM-BIO-HX-75, lot number 047F7S; Schein product code 629-8540, Model AM-BIO-HX-100, lot numbers 04454F, 045Z5L, 045Z5L5A5N, 045A5N, 045A5N5B5P, 045B5P, 045B5P5Q5W, 045Q5W, 045S64, 045T69
- 510(k) numbers
- ["K013418"]
- PMA numbers
- not on file
- Product code
- KDI
- Firm FEI
- 3002806407
- Firm city
- Chiyoda Ku
- Firm state
- not on file
- Firm country
- Japan
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28