The Recall Desk

FDA (Devices) recall action 66425

Insulet Corporation recalled 2 products on 2013-11-13

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
2013-11-13
Critical
0
Units
6,769

Why these products were recalled

Alcohol Prep Pads contained within the kit are not properly labeled.

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)··2013-11-13

    Insulet Recalls OmniPod Insulin Starter Kits Due to Mislabeling

    Insulet Corporation is recalling 1,719 OmniPod Insulin Management System Starter Kits because the included alcohol prep pads are not properly labeled.

    Product
    OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit) Product Usage: The Starter Kit (SKT-UST400) is provided to users as an introduction to the OmniPod Insulin Management System prior to initiating care. It includes the Personal Diab
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-11-13

    Insulet Recalls OmniPod Demonstration Kits Due to Mislabeling

    Insulet Corporation is recalling 5,050 OmniPod Insulin Management Product Demonstration Kits because the included alcohol prep pads are not properly labeled.

    Product
    OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490) Product Usage: The Demonstration Kit (PDK-ZXP490) is an alternate kit provided to potential patients by healthcare professionals for patients to experience what wearing a Pod may feel l
    Category
    Distribution
    0 states