Asahi Medical Co Ltd

Model Nos. APS-400S, APS-550S, APS-650S, APS-750S, APS-900S, APS-1050S. The recall is no lot specific.

Gastroenterology-Urology Devices

2

No

New Jersey, Ohio, Texas, California, Georgia, Pennsylvania, Illinois and Indiana

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

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

Gastroenterology-Urology Devices

2

No

Nationwide and Puerto Rico

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

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

Schein product code 629-4923, Model APS-21R, lot numbers U4383Y, U4383Y8K8N, X46R6V, W4797A, W4797A7X7B, X47X7B, X47X7B7Q7U, W47Q7U, W47Q7U7R7U, W47R7U, W48K8N

Gastroenterology-Urology Devices

2

No

Nationwide and Puerto Rico

Asahi APS Series Hollow Fiber Dialyzers; a wet model mutiple use dialyzer consisting of hollow fiber membranes of polysulfone 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; Model APS-21R - 2.1 m2 surface area

Schein product code 629-9041, Model CL*E12NLA, lot numbers 040408, 0404080511, 040511, 0405110610, 040610, 040909; Schein product code 629-5978, Model CL*E15NLA, lot numbers 040406, 0404060511, 040511; Schein product code 629-1824, Model CL*E18NLA, lot numbers 031020, 0310201215, 031215; Schein product code 629-7278, Model CL*E20NLA, lot numbers 020604, 0206040711, 020711;

Gastroenterology-Urology Devices

2

No

Nationwide and Puerto Rico

Terumo Clirans Series E Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (23 microns thick) of vitamin E coated copolymer cellulose housed within a polyurethane casing, filled at the factory with fluid to facilitate priming by the user, and sterilized by autoclaving before shipment; Terumo Corporation, Tokyo 151-0072, Japan; Terumo Medical Corporation, Somerset, NJ 08873 U.S.A.; Made in Japan, 24 units per case; Models CL*E12NLA - 1.2 m2 surface area, CL*E15NLA - 1.5 m2 surface area, CL*E18NLA - 1.8 m2 surface area and CL*E20NLA - 2.0 m2 surface area