Insulet Recalls OmniPod Insulin Management System Due to Needle Deployment Failure
Insulet Corporation is recalling 5,179 boxes of OmniPod Insulin Management Systems because the needle mechanism may fail to deploy or deploy with a delay.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric, as it poses a reasonable probability of serious adverse health consequences.
Plain-English summary
Insulet Corporation is recalling 5,179 boxes of the OmniPod Insulin Management System (OUS), Catalog Number 14810. The recall involves specific lot codes: L41908, L41910, and F41935. The product is intended for the subcutaneous delivery of insulin for the management of diabetes mellitus and for the quantitative measurement of glucose in fresh whole capillary blood.
The recall was initiated because the pod's needle mechanism may fail to deploy or there may be a delay in the deployment of the needle mechanism. This defect could prevent the proper administration of insulin or the measurement of glucose.
The affected products were distributed worldwide, including in the United States, Switzerland, Germany, and Israel. Consumers who have these specific lot codes should stop using the product and contact Insulet Corporation for further instructions.
The recalled product
- Product
- OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the
- Manufacturer
- Insulet Corporation
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 (3)
- Lot Codes: L41908
- L41910
- F41935
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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