Asahi Medical Co., Ltd.
Country not established
- Devices
- 16
- FDA recalls
- 11
At a glance
Market reach
- United States
- FDA recalls
What Asahi Medical Co., Ltd. makes
Asahi Medical Co., Ltd. manufactures a range of hemodialysis and hemofiltration devices, including modified and standard dialyzers (e.g., AM-R, AM-BIO, and APS series), hollow fiber kidneys, hemofilters (e.g., PAN-series), and leukocyte removal filters (e.g., Sepacell PL-series and R-500/R-500A). The company also produces hemoadsorption devices like the Hemosorba series for blood purification, designed for use in critical care and renal replacement therapies.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. Asahi Medical Co., Ltd. is based in the United States, with its products authorized for use in the U.S. market through the FDA’s regulatory framework.
Catalogue
Search and filter all 16 devicesFDA recalls
FDA recall records list 11 recalls initiated by Asahi Medical Co., Ltd., the earliest on 2001-10-01 and the most recent on 2006-10-12. By recorded status: 11 terminated. The reasons filed fall into these groups: mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2006
- 12 Oct 2006 Z-0171-2007 Unclassified (pre-2012) Terminated 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.
- 12 Oct 2006 Z-0172-2007 Unclassified (pre-2012) Terminated 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.
- 12 Oct 2006 Z-0173-2007 Unclassified (pre-2012) Terminated 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.
- 12 Oct 2006 Z-0174-2007 Unclassified (pre-2012) Terminated 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.
- 12 Oct 2006 Z-0175-2007 Unclassified (pre-2012) Terminated 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.
2005
- 31 Mar 2005 Z-0788-05 Unclassified (pre-2012) Terminated Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.
- 31 Mar 2005 Z-0789-05 Unclassified (pre-2012) Terminated Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.
- 31 Mar 2005 Z-0790-05 Unclassified (pre-2012) Terminated Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.
- 31 Mar 2005 Z-0791-05 Unclassified (pre-2012) Terminated Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.
- 31 Mar 2005 Z-0792-05 Unclassified (pre-2012) Terminated Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.
Show all 11 recalls
2001
- 1 Oct 2001 Z-0739-04 Unclassified (pre-2012) Terminated Customer reprocessing methods for the reuseable hollow fiber dialyzers may damage the hollow fibers and result in blood leaks during dialysis.
Frequently asked questions
How many devices does Asahi Medical Co., Ltd. have in the registry?
The registry currently lists 16 devices for Asahi Medical Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Asahi Medical Co., Ltd.'s devices?
Among its 16 most recently registered devices, Asahi Medical Co., Ltd. has devices listed in FDA 510(k) (16 devices).
What risk classes do Asahi Medical Co., Ltd.'s devices fall under?
Among its 16 most recently registered devices, the classes recorded for Asahi Medical Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Asahi Medical Co., Ltd.?
FDA recall records list 11 recalls initiated by Asahi Medical Co., Ltd., the most recent initiated on 12 Oct 2006. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Asahi Medical Co., Ltd. in the registry?
The most recently registered devices listed for Asahi Medical Co., Ltd. include MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT, ASAHI AM-R SERIES DIALYZERS, ASAHI HOLLOW FIBER KIDNEYS, EXCEL and ASAHI NEW PAN-SERIES HEMOFILTERS.