Simplera sensors recalled because cap label may not adhere compromising sterility
Medtronic is recalling 1,440 Simplera Sensors because the device cap label may not adhere to the sensor, compromising sterility and increasing the risk of infection.
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 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: the record states sterility may be compromised with an increased risk of infection, and no injuries are reported.
Plain-English summary
Medtronic Simplera Sensors, REF MMT-5100JD1, are being recalled because the device cap label may not adhere to the sensor, compromising the sterility of the sensor and increasing the risk of infection.
The recall covers 1,440 units from lot HG81GLZ, GTIN 20763000649580. There was no distribution in the United States; the product went to Austria, Belgium, Italy, Spain, Switzerland and the United Kingdom. The FDA has classified the action as Class II.
The enforcement record describes the sterility risk and reports no injuries. Anyone holding the affected lot should follow Medtronic's instructions rather than using the sensors.
The recalled product
- Product
- Medtronic, Simplera Sensor, REF: MMT-5100JD1
- Manufacturer
- Medtronic MiniMed, Inc.
- Category
- Medical Device — Sensor
- Affected units
- 1,440
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 # HG81GLZ/ GTIN: 20763000649580
Distribution
Distribution scope not specified by the agency.
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