Recall Z-0789-05 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Asahi Medical Co Ltd
Asahi AM-BIO-HX Extended Range Series Hollow Fiber Dialyzers; a wet model single 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 Mitosh
| Date | May 3, 2005 (initiated Mar 31, 2005) |
| Status | Terminated |
| Reason | Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis. |
| Root cause | Other |
| Action | Asahi sent Henry Schein, Inc. a recall letter dated 3/30/05, requesting the recall of the affected lots of Asahi labeled product, and Henry Schein, Inc. recalled the Asahi labeled dialyzers by letter dated 3/31/05, with a copy of the Asahi 3/30/05 letter. The accounts were informed that the dialyzers may have been exposed to temperature variances during distribution, and werw requested to cease distribution/use of the specific lots listed and return them to Henry Schein for credit. The recall was expanded to include the Terumo labeled dialyzers distributed by Asahi by Henry Schein letter dat |
| Quantity | 38,760 units |
| Distribution | Nationwide and Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013418 | AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY Asahi Medical Co., Ltd., Jul 9, 2002 |