FDA-Device2024-09-25Class II
VariSoft Infusion Set, Single Use.
Hazard
Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".
Sold states
US Nationwide distribution in the state of California.
Manufactured in
Osted, Aholmvej 1 - 3, Lejre, Denmark
Products
VariSoft Infusion Set, Single Use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3186-2024Don't want to check this manually?
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