Freestyle Libre 14 DAY Glucose Monitoring System recall
FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
Why was Freestyle Libre 14 DAY Glucose Monitoring System 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
NDC/UPC: 57599000101 All lots numbers shipped from 2/23/201 to 3/10/2021
- Product
- FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
- Recalling firm
- Cardinal Health Inc.
- Quantity
- 8,959 kits
- Distribution
- US Nationwide distribution in the states of FL, GA, SC.
- Recall date
- June 30, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)