PlainRecalls
FDA Devices Moderate Class II Ongoing

DEXCOM G6 SENSOR 3 PACK Item Number: 5447552

Reported: June 30, 2021 Initiated: March 16, 2021 #Z-1934-2021

Product Description

DEXCOM G6 SENSOR 3 PACK Item Number: 5447552

Reason for Recall

Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

Details

Recalling Firm
Cardinal Health Inc.
Units Affected
2357 kits
Distribution
US Nationwide distribution in the states of FL, GA, SC.
Location
Dublin, OH

Frequently Asked Questions

What product was recalled?
DEXCOM G6 SENSOR 3 PACK Item Number: 5447552. Recalled by Cardinal Health Inc.. Units affected: 2357 kits.
Why was this product recalled?
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 30, 2021. Severity: Moderate. Recall number: Z-1934-2021.