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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a minor labeling error on alcohol prep pads, which fits the rubric criteria for moderate severity involving minor labeling issues.
Plain-English summary
Insulet Corporation is recalling 5,050 units of the OmniPod Insulin Management Product Demonstration Kit (Model Reference Number: PDK-ZXP490). The recall is due to a labeling error where the alcohol prep pads contained within the kits are not properly labeled.
The Demonstration Kit is an alternate kit provided by healthcare professionals to potential patients to experience what wearing a Pod may feel like prior to purchase. Each kit includes a UST400 brochure, one Alcohol Pad, and a Pod. The affected lot number is L13470.
The product was distributed nationwide in the United States and in Israel. Consumers who have this specific demonstration kit should stop using the alcohol prep pads and contact their healthcare provider or Insulet Corporation for further instructions.
The recalled product
- 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…
- Manufacturer
- Insulet Corporation
- Hazard
- Affected units
- 5,050
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: L13470
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Insulet Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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