Device Recall Asahi AMBIOHX Series Hollow Fiber Dialyzers

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

Gastroenterology-Urology Devices

2

No

Nationwide and Puerto Rico

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