Recall Z-0173-2007 ยท MSE Hemodialyzer, Re-Use, Low Flux
Asahi Medical Co., Ltd
Asahi AM-BIO Series Hollow Fiber Dialyzers; a wet model single or 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
| Date | Nov 14, 2006 (initiated Oct 12, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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 |
| Quantity | 100,000 for all models |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983720 | ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO- Asahi Medical Co., Ltd., May 17, 1999 |