FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number:… recallZ-1931-2021 · Cardinal Health Inc. · initiated Mar 16, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cardinal Health Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Environmental control
What the company is doing
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)
Recall details
- Recall number
- Z-1931-2021
- Status
- Open, Classified
- Initiated by the company
- Mar 16, 2021
- Recalling firm
- Cardinal Health Inc.
- Quantity
- 2,115 kits
- Product code
- QLG
- FDA submissions
- K193371
- Distribution
- US Nationwide distribution in the states of FL, GA, SC.
Product description
FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
Code information (models, lots, serial numbers)
NDC/UPC: 57599080000 All lots numbers shipped from 2/23/201 to 3/10/2021
Other devices under the same FDA submission
1 device cleared under K193371 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- FreeStyle Libre 2 71953Abbott Diabetes Care Inc · System, Test, Blood Glucose, Over The Counter6 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 87787).
- Z-1929-2021 · Open, ClassifiedFREESTYLE LANCETS 28G 100CT Item Number:2975670
- Z-1935-2021 · Open, ClassifiedVAPORIZER VICKS 1.5GAL Item Number: 2354942
- Z-1936-2021 · Open, ClassifiedONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174
- Z-1937-2021 · Open, ClassifiedONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
- Z-1938-2021 · Open, ClassifiedONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443
- Z-1939-2021 · Open, ClassifiedONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610
- Z-1940-2021 · Open, ClassifiedONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628
- Z-1942-2021 · Open, ClassifiedACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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