Recall Z-0352-04 ยท FJI Dialyzer, Capillary, Hollow Fiber
Toray Marketing & Sales (America), Inc
Hollow Fiber Dialyzer, Model TORAYSULFONE BS-1.6, and BS-1.8
| Date | Jan 14, 2004 (initiated Dec 30, 2003) |
| Status | Terminated |
| Reason | Potential loose header (end cap) on hollow fiber dialyzers. |
| Root cause | Other |
| Action | 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. |
| Quantity | 384 units |
| Distribution | California, New Jersey, Florida, Texas, Ohio, Wisconsin, New York, and Washington. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002512 | TORAYSULFONE DIALYZER Toray Industries (America), Inc., Oct 15, 2001 |