Devices

Device Recall Asahi AMBIOHX Series Hollow Fiber Dialyzers

Model / Serial
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
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Puerto Rico
Product Description
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
Manufacturer
Asahi Medical Co Ltd
1 Event
- Recall of Device Recall Asahi AMBIOHX Series Hollow Fiber Dialyzers

Manufacturer

Asahi Medical Co Ltd

Manufacturer Address
Asahi Medical Co Ltd, 1-1 Uchiauwaicho,1-Chome, 14 Flr, Imperial Tower Bldg, Chiyoda Ku Japan
Source
USFDA

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)