Medical device recalls Moderate risk

Unomedical A/S recalls VariSoft Infusion Set, Single Use.

Recall date
July 23, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3186-2024
FDA classification
Class II
Brand / firm
Unomedical A/S
Sold / distributed
US Nationwide distribution in the state of California.

Why it was recalled

Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VariSoft Infusion Set, Single Use.

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