The Recall Desk

FDA (Devices) recall action 67714

Smiths Medical ASD, Inc. recalled 2 products on 2014-04-16

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2014-04-16
Critical
0
Units
394,080

Why these products were recalled

Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged

Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged.

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.

1–2 of 2

  • HighFDA (Devices)··2014-04-16

    Smiths Medical HOTLINE Fluid Warming Set Recall for Injection Port Leaks

    Smiths Medical is recalling HOTLINE Fluid Warming Sets because the injection port septum may leak or become dislodged.

    Product
    Smiths Medical HOTLINE¿ Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-04-16

    Smiths Medical HOTLINE Fluid Warming Set Recall for Injection Port Leaks

    Smiths Medical is recalling HOTLINE Fluid Warming Sets because the injection port septum may leak or become dislodged, potentially causing blood or IV fluid leaks.

    Product
    Smiths Medical HOTLINE¿ Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions
    Category
    Distribution
    0 states