The Recall Desk

FDA (Devices) recall action 68521

Argon Medical Devices, Inc recalled 3 products on 2014-10-01

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2014-10-01
Critical
0
Units
11,349

Why these products were recalled

UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • HighFDA (Devices)··2014-10-01

    Argon UltraStream Hemodialysis Catheters Recalled for Luer Cracking Risk

    Argon Medical Devices is recalling UltraStream Chronic Hemodialysis Catheters because cracks may develop on the red arterial luer during use.

    Product
    UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524 (24 cm), 32101528 (28cm), 32101532 (32 cm), and 32101536 (36 cm) and 32102540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-10-01

    Argon UltraStream Hemodialysis Catheter Recalled for Luer Cracking

    Argon Medical Devices is recalling UltraStream Chronic Hemodialysis Catheters because cracks may develop on the red arterial luer during attachment or manipulation.

    Product
    UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32 cm), and 32401536 (36 cm) and 32402540 (40 cm) The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-10-01

    Argon UltraStream Hemodialysis Catheter Recall Due to Luer Cracking

    Argon Medical Devices is recalling UltraStream Chronic Hemodialysis Catheters because the red arterial luer may crack during attachment or manipulation.

    Product
    UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36 cm) and 32002540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pr
    Category
    Distribution
    0 states