Hollow Fiber Dialyzer, Model FILTRYZER BK-2.IU
FDA device recall Z-0351-04 · posted 2004-01-14 · Terminated
Recall details
- Recalling firm
- Toray Marketing & Sales (America), Inc
- Reason for recall
- Potential loose header (end cap) on hollow fiber dialyzers.
- Action taken
- Firm notified all consignees by phone call on 1/2/2004 and 1/5/2004. Firm is also notifying all consignees by letter with a response form, sent by certified mail.
- Root cause
- Other
- Status
- Terminated
- Product code
- FJI
- Quantity affected
- 252 units
- Distribution
- California, New Jersey, Florida, Texas, Ohio, Wisconsin, New York, and Washington.
- Date initiated
- 2003-12-30
- Date posted
- 2004-01-14
- Date terminated
- 2004-02-03
- Location
- Houston, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FILTRYZER(TM) (K935471) | Toray Industries (America), Inc. | 1995-05-19 |