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Urgent Medical Device Field Correction: Unomedical Autosoft 90 Infusion Sets

By December 2, 2022December 5th, 2022Recalls

About the Recall:

Unomedical has issued a field correction on Autosoft 90 infusion sets with affected lot numbers which were found to have included incorrect fill volume values in the instructions for use.

Infusion of fewer units of insulin than expected can result in a higher blood glucose level than intended. This mistake only affects the initial fill/priming of the cannula. Subsequent infusions following the first infusion will perform as intended.

Click here for a full list of the affected lot numbers.

Actions to be taken by the Customer

The only action required is to use the correct value of 0.3 units for the 6 mm type and the correct value of 0.5 units for the 9 mm type when performing step 14 “Fill cannula with insulin” in the Instructions For Use.

FILLING THE CANNULA

U-100 INSULIN:
6 mm: 0.3 units (0.003 ml)
9 mm: 0.5 units (0.005 ml)