FDA Enforcement
Class II
Ongoing
DEXCOM G6 SENSOR 3 PACK Item Number: 5447552
Recall: Z-1934-2021
·
Reported June 30, 2021
Enforcement
- Recall Number
- Z-1934-2021
- Event ID
- 87787
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cardinal Health Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 30, 2021
- Initiation Date
- March 16, 2021
- Classification Date
- June 23, 2021
- Address
- 7000 Cardinal Pl, N/A, Dublin, OH, 43017-1091, United States
Description
DEXCOM G6 SENSOR 3 PACK Item Number: 5447552
Reason
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.
Code Info
NDC/UPC: 8627005303 All lots numbers shipped from 2/23/201 to 3/10/2021
Distribution
US Nationwide distribution in the states of FL, GA, SC.
Quantity
2357 kits