The Recall Desk

FDA (Devices) recall action 88455

Smiths Medical ASD Inc. recalled 2 products on 2021-09-15

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
2021-09-15
Critical
0
Units
520,163

Why these products were recalled

There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.

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.

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··2021-09-15

    NORMOFLO Irrigation Warming Sets Recalled for Aluminum Leaching Risk

    Smiths Medical is recalling NORMOFLO Irrigation Warming sets (Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700) due to potential aluminum leaching when used at lower flow rates with certain solutions and blood products. No illnesses have been reported.

    Product
    NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2021-09-15

    NORMOFLO Irrigation Fluid Warmer Recalled for Risk of Aluminum Leaching

    Smiths Medical recalls NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129 (913 units) due to potential harmful aluminum leaching when used at lower flow rates with certain solutions and blood products.

    Product
    NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
    Category
    Distribution
    1 state