FDA Medical Device Recalls (openFDA)
NxStage Medical, Inc.: NxStage Cartridge Express, CAR-170, for hemodialysis.
- Recall number
- Z-1228-2007
- Recalling firm
- NxStage Medical, Inc.
- Product
- NxStage Cartridge Express, CAR-170, for hemodialysis.
- Status
- Terminated
- Initiated
- 2007-07-27
- Posted
- 2007-09-20
- Terminated
- 2010-09-13
- Reason
- Potential for dialysate leaks from the cartridge during treatment.
- Root cause
- Process change control
- Action
- 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.
- Quantity
- 12,085 cases
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Numbers: 7037802, 703803, 703804, 7047702, 7047703, 7047704, 7047705, 7057702, 7057703, 7057704, 7057705, 7057706, 7057707, 7057708, 7057709, 7067701, 7067702,7067703, 7067705, 7067709, 7067710, 7067711, 7067712, 7067713, 7067714, 7067715, 7077703.
- 510(k) numbers
- ["K050525","K061837"]
- 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