Dexcom G4 Platinum Pediatric Receiver Recall for Missing Audible Alarms
Dexcom Inc is recalling 19,586 G4 Platinum Pediatric Receivers because they may fail to provide intended audible alarms or alerts.
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 involves a medical device where the failure to provide audible alarms poses a risk of harm to users with diabetes, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Dexcom Inc is recalling 19,586 units of the Dexcom G4 PLATINUM (Pediatric) Receiver with Share. The affected products include receivers in black, pink, and blue colors, identified by specific part numbers and lot numbers listed in the recall documentation. The devices are intended to detect trends and track glucose patterns in persons with diabetes.
The recall was initiated because customers may not receive an intended audible alarm or alert if they are relying on hearing the alarm or alert. This defect could prevent users from being notified of critical glucose readings through sound.
The affected units were distributed worldwide, including in the United States, Canada, and numerous countries in Europe, Asia, Africa, and the Middle East. Consumers who have these specific receivers should check their lot numbers against the recall list and contact Dexcom Inc for further instructions.
The recalled product
- Product
- Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). Intended to detect trends and track glucose patterns in per
- Manufacturer
- Dexcom Inc
- Affected units
- 19,586
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Dexcom 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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