Dexcom G6 Sensor 3-Pack Recalled for Temperature-Related Measurement Errors
Cardinal Health is recalling 2,357 kits of Dexcom G6 Sensor 3-Pack due to temperature exposure during shipping that may cause inaccurate glucose readings. Affected units were distributed in Florida, Georgia, and South Carolina.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—temperature-exposed sensors may produce inaccurate glucose readings—but no actual incidents have been documented. This qualifies as high severity because it involves a risk-of-harm medical device where injury has not yet been reported.
Plain-English summary
Cardinal Health Inc. is recalling 2,357 kits of Dexcom G6 Sensor 3-Pack (Item Number: 5447552). The affected devices were distributed nationwide in Florida, Georgia, and South Carolina. The recalled lot numbers were shipped between February 23, 2021 and March 10, 2021, and are identified by NDC/UPC: 8627005303.
The devices were exposed to temperature excursions of 31.9°F that occurred intermittently over a 2-hour and 15-minute period during shipping. This temperature exposure may cause the glucose sensors to produce inaccurate results.
Users of the affected Dexcom G6 Sensor 3-Pack kits should immediately stop using them and contact Cardinal Health for a replacement. Patients should consult with their healthcare provider regarding continuous glucose monitoring alternatives during this recall.
The recalled product
- Product
- DEXCOM G6 SENSOR 3 PACK Item Number: 5447552
- Manufacturer
- Cardinal Health Inc.
- Hazard
- Affected units
- 2,357
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- NDC/UPC: 8627005303 All lots numbers shipped from 2/23/201 to 3/10/2021
Distribution
Part of a larger recall action
This product is one of 14 recalled by Cardinal Health 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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