The Recall Desk
HighFDA (Devices)·Z-1930-2021·Announced 2021-06-30

FREESTYLE LIBRE 14 DAY glucose monitoring system recalled for temperature exposure

Cardinal Health is recalling 8,959 glucose monitoring kits due to temperature exposure during shipping that may result in inaccurate readings. Affected devices were distributed nationwide.

What this means for you

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 of a medical device with risk-of-harm potential. Temperature exposure may cause inaccurate glucose readings, which could affect diabetes management. The source text does not report illnesses, injuries, or hospitalizations, making this a theoretical risk scenario rather than confirmed harm.

Plain-English summary

The FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM (Item Number 5479084, NDC/UPC 57599000101) is being recalled by Cardinal Health Inc. The recall affects 8,959 kits that were shipped between February 23, 2021 and March 10, 2021.

During shipping, the devices were exposed to temperatures of 31.9°F intermittently over a 2 hour and 15 minute period. This temperature excursion may cause the glucose monitoring system to provide inaccurate results, which could affect diabetes management and glucose tracking reliability.

The affected products were distributed nationwide in Florida, Georgia, and South Carolina. Patients who use this glucose monitoring system should consult with their healthcare provider if they have concerns about device accuracy or their blood glucose readings.

Cardinal Health is the recalling manufacturer. Consumers with questions about this recall should contact their healthcare provider or Cardinal Health for guidance on replacement or alternatives.

The recalled product

Product
FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
Manufacturer
Cardinal Health Inc.
Category
Medical Device — Glucose Monitoring
Hazard
  • inaccurate-results
  • device-malfunction
  • temperature-damage

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: 57599000101 All lots numbers shipped from 2/23/201 to 3/10/2021

Distribution

Distributed nationwide across the United States.

Related recalls

Same category