FDA-Device2022-10-05Class II
Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.
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.
Sold states
Distribution was made to California. There was no government/military distribution.
Affected count
1,643,320 units
Manufactured in
Aaholmvej 1 - 3, OSTED, LEJRE, N/A, Denmark
Products
Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1810-2022Don't want to check this manually?
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