AA-Med Pty Ltd is recalling two lots of Dexcom G7 sensors. These lots were identified for disposal and destruction in the USA due to incomplete sterilisation and deployment failure during testing. The devices from both lots were stolen during the disposal process and sold to third parties via unauthorised supply channels.
| Product Name | ARTG | Product Code | Lot Numbers |
|---|---|---|---|
Dexcom G7 sensors
| 472165 | STP-AT-012 | 1725204004 1725069002 |
As the supply channels for these lots cannot be established, the risk of some devices reaching the Australian market cannot be excluded.
This problem only affects the lot numbers listed above; no other lots are impacted.
What are the risks?
Risks associated with use of the affected sensors include:
- Skin infections
- Inaccurate or loss of readings
- Missed detection of hypoglycaemia (low blood glucose) or hyperglycaemia (high blood glucose), which could lead to serious health consequences.
What should I do?
- Immediately discontinue use and dispose of affected products.
- Replace the affected sensor with an unaffected sensor or use a blood glucose meter for glucose monitoring.
- Contact Dexcom Technical Support to request a replacement.
- If you have symptoms of infection or inflammation, redness, swelling, or pain, at the insertion site, contact a healthcare provider.
Further information
Please contact Dexcom Technical Support on 1300 851 056 for further information.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to our monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.