Z-1931-2021Class II

FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877

Name: Z-1931-2021 FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
Creator: Cardinal Health Inc.
Published: 2021-03-16
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-03-16 / Open, Classified / root cause: manufacturing process

FDA source

Cardinal Health Inc. began a recall of FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877 on 2021-03-16. FDA classified it as Class II and gives the reason as "Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1931-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-03-16
Posted: 2021-06-23
Recalling firm: Medtronic, Inc.
Product: FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
Product code: QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Reason for recall: Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: On 03/16/2021, Cardinal Health issued an Urgent Medical Device Removal notice to customer via letter notifying them a recall is being initiated as a precautionary measure as a result of exposure to temperatures outside of the products labeling requirements. Actions Required 1. INSPECT your inventory for the affected product. 2. SEGREGATE and QUARANTINE all affected product. 3. RETURN the enclosed acknowledgment form via fax to 1-817-868-5362 or email to [email protected], even if you do not have any product on hand. 4. CONTACT Inmar to arrange for return and credit of any affected product: 1-855-696-2074 (9:00 AM to 5:00 PM, Monday thru Friday)
Quantity in commerce: 2,115 kits
Distribution: US Nationwide distribution in the states of FL, GA, SC.
Product codes and lots: NDC/UPC: 57599080000 All lots numbers shipped from 2/23/201 to 3/10/2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1931-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1929-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23
Z-1930-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23
Z-1931-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23
Z-1932-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23
Z-1933-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23
Z-1934-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23
Z-1935-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23
Z-1936-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23
Z-1937-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23
Z-1938-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23
Z-1939-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23
Z-1940-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23
Z-1941-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23
Z-1942-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-23

Product code QLG

K193371Class IIFreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. / cleared 2020-06-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)