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FDA Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities. --------------------------------------------------------------------------------

July 14, 2004

PRODUCT

a) NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-124, 6 units per case. Recall # Z-1069-04;

b) NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-153 Cartridge Express. 6 units per case. Recall # Z-1070-04;

c) NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model # CAR-154 Cartridge Express, 6 units per case. Recall # Z-1071-04.

CODE

a) Lot Numbers from and including FG-031216-01 to FG-040322-01;

b) Lot Numbers from and including FG-031216-01 to FG-040322-01;

c) Lot Numbers from and including FG-031216-01 to FG-040322-01. RECALLING FIRM/MANUFACTURER NxStage Medical, Inc., Lawrence, MA, by recall notice dated April 14, 2004. Firm initiated recall is ongoing.

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. VOLUME OF PRODUCT IN COMMERCE 1,188 units.

DISTRIBUTION

CA, IL, IN, MD, IA, MO, NJ, OH, and VT