FDA-Device2024-09-25Class II
VariSoft Infusion Set, Single Use.
Unomedical A/S
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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