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Insulet Corporation recalls Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318
Recalled March 17, 2021 · FDA recall Z-1203-2021 · Insulet
Hazard
Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery and hypoglycemia. Only Outside the US (OUS): Error in the Omnipod DASH User Guide text, page 6 of the User Guide, the text states that the comma (,) is not used for the decimal on the PDM, when in fact it is the period (.) that is not used.If a user were to use the period as a decimal separator when entering a bolus value, this decimal separator would not be recognized by the device and any numbers entered after the period could result in a larger value than intended · FDA Class II
Units
21,723 guides
Sold at
Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland
Description
Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery and hypoglycemia. Only Outside the US (OUS): Error in the Omnipod DASH User Guide text, page 6 of the User Guide, the text states that the comma (,) is not used for the decimal on the PDM, when in fact it is the period (.) that is not used.If a user were to use the period as a decimal separator when entering a bolus value, this decimal separator would not be recognized by the device and any numbers entered after the period could result in a larger value than intended
Product
Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland
Manufacturer(s)
Insulet Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →