Asahi Medical Co., Ltd Asahi AM-R Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of cuprammonium rayon housed within a plastic casing of styrene butadiene block polymer, 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 AM-NR-65U - 1.3 m2 surface area, Model AM-NR-75U - 1.5 m2 surface area and Model AM-NR-100U - 2.0 m2 surface area Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Asahi AM-R Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of cuprammonium rayon housed within a plastic casing of styrene butadiene block polymer, 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 AM-NR-65U - 1.3 m2 surface area, Model AM-NR-75U - 1.5 m2 surface area and Model AM-NR-100U - 2.0 m2 surface area
Brand
Asahi Medical Co., Ltd
Lot Codes / Batch Numbers
Model AM-NR-65U, Model AM-NR-75U and Model AM-NR-100U, all lots
Products Sold
Model AM-NR-65U, Model AM-NR-75U and Model AM-NR-100U, all lots
Asahi Medical Co., Ltd is recalling Asahi AM-R Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of due to There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple Use Dialyzers at the end of treatment, possi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple Use Dialyzers at the end of treatment, possibly damaging the dialyzer nozzle.
Recommended Action
Per FDA guidance
Asahi sent Safety Alert letters on 10/12/06 to their re-use dialyzer customers advising them of the reports of difficulty separating the blood set from the dialyzer and not to use the Gambro Cartridge Blood Set with Asahi Reuse/Multiple Use Dialyzers in a reuse situation. Enclosed were copies of the temporary revision Instructions For Use with the following warning added at the top of the page: 'Additional Warning for Reuse/Multiple Use Dialyzers: Ashai Reuse/Multiple use dialyzers must not be used in connection with the Gambro cartridge Blood Set in a reuse environment.' Any questions were directed to Karen Borling, RN at 847-498-8500.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026