FDA: Insulet Omnipod DASH Recall Deemed Class I
Batteries used in the diabetes management devices may leak fluids or overheat, posing a potential fire risk. The recall, which the US FDA has now announced qualifies as high-risk class I, was first announced in October.
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Cables and the charging port for the systems’ controller may overheat due to a poor connection, the company said.
Insulet has recalled its Omnipod DASH personal diabetes manager after reports from users of battery issues. The company says it is replacing the devices.
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