Agency classClass IOur severity:Severe FDA (Devices)·Z-1335-2016·Announced 2016-04-20

Dexcom G4 Platinum Pediatric Receiver Recall for Missing Audible Alarms

Dexcom Inc is recalling 18,004 G4 Platinum Pediatric Receivers because they may fail to provide intended audible alarms or alerts.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert."

Plain-English summary

Dexcom Inc is recalling 18,004 units of the Dexcom G4 PLATINUM (Pediatric) Receiver. The affected devices are identified by specific receiver kit numbers and lot numbers listed in the official recall documentation. The product is 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 compromise the device's ability to notify users of glucose trends 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 and kit numbers against the recall list and contact Dexcom Inc for further instructions.

The recalled product

Product: Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with…
Manufacturer: Dexcom Inc
Category: Medical Device — Glucose Monitoring
Hazard: alarm-failure
Affected units: 18,004

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.

See all 6 products in this recall →

Same manufacturer · Dexcom Inc

See all →

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Same hazard · alarm failure