Hemodialyzer, Re-use, Low Flux
Gastroenterology, Urology · 21 CFR 876.5820
Recent MDR events
53 adverse event reports on file
- F80A DIALYZER FINISHED ASSYMar 6, 2014MalfunctionOgden Manufacturing1713747-2014-00091
- F80A DIALYZER FINISHED ASSYMar 6, 2014MalfunctionOgden Manufacturing1713747-2014-00092
- F80A DIALYZER FINISHED ASSYMar 6, 2014MalfunctionOgden Manufacturing1713747-2014-00093
- F80A DIALYZER FINISHED ASSYMar 6, 2014MalfunctionOgden Manufacturing1713747-2014-00094
- F80A DIALYZER FINISHED ASSYMar 6, 2014MalfunctionOgden Manufacturing1713747-2014-00095
- F6 DIALYZER FINISHED ASSYMay 26, 2011MalfunctionOgden Manufacturing1713747-2011-00016
- F5 DIALYZER FINISHED ASSYMay 19, 2011MalfunctionOgden Manufacturing1713747-2011-00012
- F3 DIALYZER FINISHED ASSYApr 20, 2011InjuryOgden Manufacturing1713747-2011-00011
- FUSA F4 (HF/PS/0.65/L)Mar 29, 2011MalfunctionOgden Manufacturing1713747-2011-00009
- F3 DIALYZER FINISHED ASSYFeb 18, 2011InjuryOgden Manufacturing1713747-2011-00005
Event type breakdown
Recalls
2 recall events for this product code
- Asahi Medical Co., LtdTerminatedNov 14, 2006
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 cell
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.
Z-0173-2007 · View FDA record ↗ - Asahi Medical Co., LtdTerminatedNov 14, 2006
Asahi AM-BIO D Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted ce
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.
Z-0174-2007 · View FDA record ↗
Registered firms
1 firms currently registered for this product code
510(k) clearances
7 clearances for this product code
- Baxter Healthcare CorpNov 15, 2000
K001685 · PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210
- Asahi Medical Co., Ltd.May 17, 1999
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-
- Fresenius USA, Inc.Sep 15, 1998
K970700 · FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX
- Fresenius Medical Care North AmericaAug 27, 1998
K974090 · 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS
- Baxter Healthcare CorpNov 12, 1997
K970661 · CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)
- Baxter Healthcare CorpNov 12, 1997
K970654 · CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
- Asahi Medical Co., Ltd.Sep 30, 1997
K970650 · ASAHI AM-R SERIES DIALYZERS