DEXCOM G6 SENSOR 3 PACK Item Number: 5447552
- Company
- Cardinal Health Inc.
- Recall Initiated
- March 16, 2021
- Recall Number
- Z-1934-2021
- Quantity
- 2357 kits
- Firm Location
- Dublin, OH
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.
Distribution
US Nationwide distribution in the states of FL, GA, SC.
Lot / Code Info
NDC/UPC: 8627005303 All lots numbers shipped from 2/23/201 to 3/10/2021
Root Cause
Environmental control
Action Taken
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)