Examples of misuse include exposure to liquids, damage, and introduction of foreign material into the ports. The potential for overheating, spark, or fire may occur when charging the Reader with non- Abbott adapters or non-Abbott USB cables combined with misuse of the Reader and its components. This does not affect any of the FreeStyle Libre family of sensors. Reason for RecallĪbbott is recalling the FreeStyle Libre, Libre 14 day, and Libre 2 Flash Glucose Management Systems’ reader devices, which use rechargeable lithium-ion batteries, may get extremely hot, spark, or catch on fire if not properly stored, charged, or used with its Abbott provided USB cable and power adapter. They are indicated for single patient use, and require a prescription. These devices help people manage diabetes by detecting trends and tracking patterns in glucose levels so treatment can be adjusted as needed. The FreeStyle Libre, Libre 14 day, and Libre 2 Flash Glucose Monitoring Systems are intended to provide continuous monitoring of glucose levels. Date Initiated by Firm: February 13, 2023.Devices Recalled in the U.S.: 4,210,785.Distribution Dates: Beginning November 2017.Product Models: all Reader serial numbers.Product Name: FreeStyle Libre Flash Glucose Monitoring System, FreeStyle Libre 14 day Flash Glucose Monitoring System, FreeStyle Libre 2 Flash Glucose Monitoring System. Use of these devices may cause serious injuries or death. The FDA has identified this as a Class I recall, the most serious type of recall. In this case, the firm is correcting the product labeling and not physically removing all the readers as part of this recall.Īdditional information, including recommendations, and what to do if a reader needs to be returned can be found in the What to Do section. If you are not experiencing problems with the Abbott provided Reader and you have the Abbott provided USB cable and power adapter, you can continue to use the Abbott provided Reader, USB cable, and power adapter.Ī medical device recall means a firm’s removal or correction of a medical device. On April 12, 2023, the FDA added information for patients about Abbott’s April 2023 Medical Device Correction letter.
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