NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-153 Cartrid
FDA device recall Z-1070-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- NxStage Medical, Inc.
- Reason for recall
- Pinhole leaks on the replacement (RF) side FMP bag in certain lots of its disposable cartridge balance chambers resulting in loss of dialysate or ultrafiltrate
- Action taken
- Voluntary recall notice dated 4/14/04 sent UPS, overnight with signature required to both ICU/CCU (Acute accounts) and Chronic accounts. Firm to remove and replace product that contains a disposable component from a new supplier that has demonstrated to be less reliable resulting in pinhole leaks.
- Root cause
- Other
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 402 units
- Distribution
- CA, IL, IN, MD, IA, MO, NJ, OH, VT
- Date initiated
- 2004-04-14
- Date posted
- 2004-07-20
- Date terminated
- 2004-07-13
- 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 |
|---|---|---|
| MODIFICATION TO NXSTAGE SYSTEM ONE (K040696) | Nxstage Medical, Inc. | 2004-05-26 |