NxStage Medical, Inc. NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-124, 6 units per case. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-124, 6 units per case.
Brand
NxStage Medical, Inc.
Lot Codes / Batch Numbers
Lot Numbers from and including FG-031216-01 to FG-040322-01
Products Sold
Lot Numbers from and including FG-031216-01 to FG-040322-01
NxStage Medical, Inc. is recalling NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Mo due to Pinhole leaks on the replacement (RF) side FMP bag in certain lots of its disposable cartridge balance chambers resulting in loss of dialysate or ultr. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IL, IN, IA, MD, MO, NJ, OH, VT
Page updated: Jan 10, 2026