Recall Z-1931-2021 ยท QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Cardinal Health Inc.
FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
| Date | Mar 16, 2021 |
| Status | Open, Classified |
| Reason | 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 | 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 rxrecalls@inmar.com, even if you do not have any product on hand. 4. CONTACT Inmar to arrange for return and credit of any affected product: |
| Quantity | 2,115 kits |
| Distribution | US Nationwide distribution in the states of FL, GA, SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193371 | FreeStyle Libre 2 Flash Glucose Monitoring System Abbott Diabetes Care, Inc., Jun 12, 2020 |