NxStage Cartridge Express, CAR-170, for hemodialysis.
FDA device recall Z-1228-2007 · posted 2007-09-20 · Terminated
Recall details
- Recalling firm
- NxStage Medical, Inc.
- Reason for recall
- Potential for dialysate leaks from the cartridge during treatment.
- Action taken
- NxStage initiated the recall by letter on 8/24/07 advising users of the specific lots to be removed from use. Prior notifications were issued on July 27, 2007, July 30, 2007 and July 31, 2007 notifying users of the potential for leaks and instructions to detect leaks prior to use.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 12,085 cases
- Distribution
- Nationwide
- Date initiated
- 2007-07-27
- Date posted
- 2007-09-20
- Date terminated
- 2010-09-13
- Location
- Lawrence, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NXSTAGE CARTRIDGE EXPRESS (K061837) | Nxstage Medical, Inc. | 2006-07-31 |
| NXSTAGE SYSTEM ONE (K050525) | Nxstage Medical, Inc. | 2005-06-24 |