Unomedical A/S: Device Recall

Recall #Z-3186-2024 · 07/23/2024

Class II: Risk

Recall Details

Recall Number
Z-3186-2024
Classification
Class II
Product Type
Device
Recalling Firm
Unomedical A/S
Status
Ongoing
Date Initiated
07/23/2024
Location
Lejre, Denmark
Voluntary/Mandated
Voluntary: Firm initiated

Reason for Recall

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

Product Description

VariSoft Infusion Set, Single Use.

Distribution Pattern

US Nationwide distribution in the state of California.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.