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Unomedical A/S recalls Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusio
Recalled October 5, 2022 · FDA recall Z-1810-2022 · Unomedical A/S
Hazard
The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insulin infusion to be fewer units than intended. · FDA Class II
Units
1,643,320 units
Sold at
Distribution was made to California. There was no government/military distribution.
Description
The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insulin infusion to be fewer units than intended.
Product
Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.
Manufacturer(s)
Unomedical A/S
Made in
Denmark
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →