The U.S. Food and Drug Administration (FDA) has issued a Class I recall, the most severe type of recall, for specific FreeStyle Libre Flash Glucose Monitoring Systems models. These devices are intended to help people with diabetes manage their condition by continuously monitoring glucose levels. The recall affects all Reader serial numbers distributed in the U.S. since November 2017, with a total of 4,210,785 devices being recalled.
The recall involves the FreeStyle Libre, Libre 14-day, and Libre 2 Flash Glucose Monitoring Systems, which are designed for single-patient use and require a prescription. Abbott, the manufacturer of these devices, has identified an issue with the Reader devices that use rechargeable lithium-ion batteries. If not properly charged, stored, or used with the Abbott-provided USB power adapter and cable, the Reader may become extremely hot, spark, or catch on fire, posing serious injury or death risks to users.
The recall does not include any of the FreeStyle Libre family of sensors. The risk of spark, overheating, or fire might happen when charging the Reader with non-Abbott adapters or non-Abbott USB cables combined with the misuse of the Reader and its components. Abbott-provided USB cables and power adapters limit the power provided to safely charge the battery, whereas third-party cables and adapters may allow higher power, increasing the risk of overheating or fire.
There have been 88 reported incidents, including seven fires and at least one injury. Users of the FreeStyle Libre, Libre 14-day, or Libre 2 Glucose Monitoring Systems, as well as healthcare providers with patients using these systems, may be affected by this recall.
On February 13, 2023, Abbott sent some users of the FreeStyle Libre family of Readers an Urgent Medical Device Correction letter. The FDA recommends that users experiencing any of the listed problems or not having the Abbott-provided USB cable and power adapter stop using the FreeStyle Libre Reader and switch to a backup method. Users needing a replacement Reader, USB cable, or power adapter should contact Abbott’s Customer Service at 1-855-632-8658.
To avoid battery swelling, leakage, extreme overheating, and/or fire, Abbott recommends charging the Reader battery only with the Abbott-supplied USB cable and power adapter, not exposing the Reader, power adapter, or USB cable to water or other liquids, and storing the Reader between -4 °F and 140 °F. Users should also avoid getting dirt, dust, blood, water, control solution, bleach, or any other substance in the test strip or USB port.
Abbott has provided additional information and resources on www.FreeStyleBattery.com, including a Reader Test to determine if a user’s current Reader needs to be replaced. For any questions about this recall, users should contact Abbott Customer Service. Their contact information can be found on the company’s recall website FreeStyleBattery.com.
If you or a loved one have been harmed or suffered substantial property damage caused by this recalled medical device, contact Parker Waichman LLP for a free case review and to discuss the possibility of recovering substantial monetary compensation.
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