The Recall Desk

FDA (Devices) recall action 86477

Becton Dickinson & Company recalled 2 products on 2020-11-04

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
2020-11-04
Critical
0
Units
117

Why these products were recalled

Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit.

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

  • ModerateFDA (Devices)··2020-11-04

    Bard 3F SL PowerMidline Kit Recalled for Missing Stylet Assembly

    Becton Dickinson is recalling 45 Bard 3F SL PowerMidline kits in Italy, Spain, and the UK because they lack the stylet/T-lock assembly listed on the label.

    Product
    Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media Ref: P6153118
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-11-04

    Becton Dickinson Recalls Bard 3F SL PowerMidline Full Kits

    Becton Dickinson is recalling Bard 3F SL PowerMidline Full Kits because they may lack the stylet/T-lock assembly, potentially causing procedural delays.

    Product
    Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media Ref: P6153208
    Category
    Distribution
    0 states