BEUDAMED
    FDA Recall Terminated

    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 · Initiated April 14, 2004

    Recall

    Recall Number
    Z-1069-04
    Event Number
    29268
    Firm
    NxStage Medical, Inc.
    FEI Number
    3003464075
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 14, 2004
    Posted
    July 20, 2004
    Terminated
    July 13, 2004
    Address
    439 South Union Street, Floor 5th, Lawrence, MA, 01843-2800

    Description

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

    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

    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.

    Distribution

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

    Quantity

    234 units