Asahi APS Series Dialyzers, Model Nos. APS-400S, APS-550S, APS-650S, APS-750S, APS-900S, APS-1050S; the dialyzers are in
FDA device recall Z-0739-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Asahi Medical Co Ltd
- Reason for recall
- Customer reprocessing methods for the reuseable hollow fiber dialyzers may damage the hollow fibers and result in blood leaks during dialysis.
- Action taken
- Asahi visited each of the U.S. customers starting on 10/1/01, observing how the facility handles the dialyzer before pre-cleaning, during pre-cleaning and priming. The users were retrained in the reprocessing steps, emphasizing the controls and care to be taken during pre-cleaning, including the verification of water pressure.
- Root cause
- Other
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 180,000 units estimated
- Distribution
- New Jersey, Ohio, Texas, California, Georgia, Pennsylvania, Illinois and Indiana
- Date initiated
- 2001-10-01
- Date posted
- 2004-07-20
- Date terminated
- 2004-03-24
- Location
- Chiyoda Ku, Japan
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) (K001250) | Asahi Medical Co., Ltd. | 2000-08-16 |