FDA Medical Device Recalls (openFDA)
NxStage Medical, Inc.: NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-153 Cartridge Express. 6 units per case.
- Recall number
- Z-1070-04
- Recalling firm
- NxStage Medical, Inc.
- Product
- NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-153 Cartridge Express. 6 units per case.
- Status
- Terminated
- Initiated
- 2004-04-14
- Posted
- 2004-07-20
- Terminated
- 2004-07-13
- Reason
- 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
- Root cause
- Other
- Action
- 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.
- Quantity
- 402 units
- Distribution
- CA, IL, IN, MD, IA, MO, NJ, OH, VT
- Lot, serial or model codes
- Lot Numbers from and including FG-031216-01 to FG-040322-01
- 510(k) numbers
- ["K040696"]
- PMA numbers
- not on file
- Product code
- KDI
- Firm FEI
- 3003464075
- Firm city
- Lawrence
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28