NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model # CAR-154 Cartridge Express, 6 units per case.
- Company
- Nxstage Medical, Inc.
- Recall Initiated
- April 14, 2004
- Posted
- July 20, 2004
- Terminated
- July 13, 2004
- Recall Number
- Z-1071-04
- Quantity
- 552 units
- Firm Location
- Lawrence, MA
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
Distribution
CA, IL, IN, MD, IA, MO, NJ, OH, VT
Lot / Code Info
Lot Numbers from and including FG-031216-01 to FG-040322-01
Root Cause
Other
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.
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