Recall Z-0175-2007
Asahi Medical Co., Ltd · initiated October 12, 2006
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
Codes / lots: Model AM-NR-65U, Model AM-NR-75U and Model AM-NR-100U, all lots
Reason for recall
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.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-0175-2007
- Initiated
- October 12, 2006
- Posted by FDA
- November 14, 2006
- Terminated
- November 28, 2007
- Product code
- FJI – Dialyzer, Capillary, Hollow Fiber
- Quantity
- 100,000 for all models
- Distribution
- Nationwide
- Recalling firm
- Asahi Medical Co., Ltd, Northbrook, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0171-2007 | Asahi APS Series Multiple-Use Hollow Fiber Dialyzers; a wet model multiple use dialyzer…There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple… | 10/12/2006Terminated |
| Z-0172-2007 | Asahi Rexeed Series Multiple-Use Hollow Fiber Dialyzers; a wet model multiple use…There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple… | 10/12/2006Terminated |
| Z-0173-2007 | Asahi AM-BIO Series Hollow Fiber Dialyzers; a wet model single or multiple use dialyzer…There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple… | 10/12/2006Terminated |
| Z-0174-2007 | Asahi AM-BIO D Series Hollow Fiber Dialyzers; a dry model single or multiple use…There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple… | 10/12/2006Terminated |