Recall NoticeDear Valued Customer,
We are writing to inform you of a voluntary medical device correction initiated by Abbott Diabetes Care for certain Readers in the FreeStyle Libre Family of products, including FreeStyle Libre, FreeStyle Libre 14 day and FreeStyle Libre 2 Readers.
The Readers use lithium-ion batteries, which are generally safe when used correctly. However, they may pose a fire hazard if they become damaged. Abbott has received reports from some users regarding Reader issues, including battery swelling and, in rare cases, extreme overheating which may pose a fire hazard. Their ongoing investigation has determined that using a charging cable or power adapter that was not included with the FreeStyle Libre system may increase the risk of fire hazard. Abbott is updating the instructions for use to address this issue.
Action you need to take:
Abbott has prepared several informational links found below in the resource section of this email. Please utilize the links included to acknowledge receipt of this notice and perform a FreeStyle Reader Battery Check to determine if your Reader needs to be replaced.
Resources & Acknowledgement:
1. Review the Urgent Device Correction Notice.
2. Acknowledge the notice by signing the reader acknowledgment form.
3. Perform a Reader Replacement Check.
If you have questions regarding the lithium-ion battery issue, please contact Abbott's Customer Care team directly at 1-855-632-8658.
Sincerely,
Performance Home Medical
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