To: All Medical Device Establishment

Subject: Regarding Recall of Continuous Glucose Monitoring System from Dexcom

After Compliments,

Recall of Continuous Glucose Monitoring System from Dexcom

Device Name: Continuous Glucose Monitoring System from Dexcom

Manufacturer: Dexcom Inc

Local agent: Scientific Pharmacy

Affected devices:

• STK-GT-001 lot 19492808

• STK-D7-014 lot 20280910

• STK-D7-014 lot 20280914

Reason:

A manufacturing defect has been identified in the foam used in the production of some devices, which may result in the absence of audible alerts in the affected devices mentioned above.

Instructions:

1. Immediately stop using the affected devices.

2. Contact the authorized distributor to replace the affected devices.

3. Conduct regular testing of the speaker to ensure the audio alerts are functioning properly and there is no defect.

Report Any issues related to medical devices and supplies can be reported via the following email: vigilance-md@moh.gov.om