Dexcom Inc recalls Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics);

Recalled April 20, 2016 · FDA recall Z-1338-2016 · Dexcom

Hazard

Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. · FDA Class I

Units

19,586

Sold at

Worldwide Distribution-US (nationwide), Canada, Italy, Netherlands, Belgium, Norway, New Zealand, Poland, Sweden, Denmark, Slovenia, Turkey, South Africa, India, Israel, Hungary, Hong Kong, UK, Ireland, France, Finland, Spain, Portugal, Colombia, Chile, Germany, Austria, Switzerland, Kuwait, United Arab Emirates, Australia, Czech Republic, Bahrain, Lebanon, and Qatar.

Description

Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.

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 persons with diabetes.

Manufacturer(s)

Dexcom Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →