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Terminated

NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-153 Cartridge Express. 6 units per case.

FDA Recall Z-1070-04 · Posted 2004-07-20

Recalling FirmNxStage Medical, Inc.
Recall StatusTerminated
Product CodeKDI
Date Initiated2004-04-14
Date Terminated2004-07-13
Product Quantity402 units

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

Firm 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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040696MODIFICATION TO NXSTAGE SYSTEM ONENxstage Medical, Inc. · 2004-05-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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