Medtronic MiniMed Pro-set Infusion Sets Recalled for Insulin Over-delivery Risk
Medtronic is recalling 5,842 MiniMed Pro-set infusion sets worldwide due to a potential risk of over-delivering insulin.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves the potential for over-delivery of insulin, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Medtronic Inc. is recalling 5,842 units of Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281) infusion sets. The affected units were distributed worldwide and include lot numbers 6211649 and 6207537.
The recall is being conducted because the infusion sets have the potential for over-delivery of insulin. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected infusion sets and contact Medtronic for further instructions or a replacement.
The recalled product
- Product
- Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)
- Manufacturer
- Medtronic Inc.
- Hazard
- Affected units
- 5,842
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 (2)
- Lot Numbers: 6211649
- 6207537
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Medtronic Inc. 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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