Dexcom G7 Continuous Glucose Monitoring System sensors recalled
Dexcom is recalling two lots of G7 glucose sensors that were stolen during destruction and sold through unauthorized channels. These sensors were designated for destruction due to improper sterilization, increased infection risk, and potential for inaccurate or missing readings.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a medical device with potential for serious patient harm. Lot 1725204004 presents risk of skin infection from improper sterilization; Lot 1725069002 presents risk of missed hyperglycemic detection and incorrect treatment decisions that could result in patient injury requiring medical intervention.
Plain-English summary
Dexcom, Inc. is recalling Dexcom G7 Continuous Glucose Monitoring System sensors from two lots: 1725204004 and 1725069002. These sensors were originally designated as scrap and intended for destruction but were stolen during the destruction process and subsequently sold to pharmacies and distributors by Pharmsource, LLC.
Lot 1725204004 was designated for destruction because the G7 sensors were not properly sterilized and carry an increased risk of skin infection if used.
Lot 1725069002 was designated for destruction due to an increased risk of having no sensor readings available or experiencing sensor inaccuracy, including the potential for missed detection of a hyperglycemic event or incorrect treatment decisions that can result in patient injury, including medical intervention to prevent permanent injury or impairment. Additionally, due to unknown storage and handling conditions these sensors may have undergone during unauthorized distribution, they may present additional risk.
Consumers who have these sensors should stop using them and contact their healthcare provider. Lot 1725204004 has been identified in the United States; Lot 1725069002 has been identified in the United States and in Australia, Austria, Canada, Czech Republic, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, South Korea, Kuwait, Netherlands, Poland, Portugal, Qatar, Singapore, Spain, Switzerland, Turkey, United Arab Emirates, and the United Kingdom.
The recalled product
- Product
- Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog Number: STP-AT-012 Software Version: N/A Product Description: Dexcom G7 US Retail Sensor/Transmitter 1-pack Component: Dexcom G7 Continuous…
- Manufacturer
- Dexcom, Inc.
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 Code: UDI-DI: 00386270004109 Lot Numbers: 1725204004 and 1725069002
Distribution
Distribution scope not specified by the agency.
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