FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
Reported: June 30, 2021 Initiated: March 16, 2021 #Z-1930-2021
Product Description
FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
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
- 8,959 kits
- Distribution
- US Nationwide distribution in the states of FL, GA, SC.
- Location
- Dublin, OH
Frequently Asked Questions
What product was recalled? ▼
FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084. Recalled by Cardinal Health Inc.. Units affected: 8,959 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-1930-2021.
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