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U.S. Department of Health and Human Services

Class 2 Device Recall FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM

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  Class 2 Device Recall FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM see related information
Date Initiated by Firm March 16, 2021
Create Date June 23, 2021
Recall Status1 Open3, Classified
Recall Number Z-1931-2021
Recall Event ID 87787
510(K)Number K193371  
Product Classification Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delive - Product Code QLG
Product FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
Code Information NDC/UPC: 57599080000 All lots numbers shipped from 2/23/201 to 3/10/2021
Recalling Firm/
Manufacturer		 Cardinal Health Inc.
7000 Cardinal Pl
Dublin OH 43017-1091
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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: 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = QLG and Original Applicant = Abbott Diabetes Care Inc.
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