FDA recall Z-3186-2024

Unomedical A/S · Class II · device

Product

VariSoft Infusion Set, Single Use.

Reason for recall

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

Distribution

US Nationwide distribution in the state of California.

Key facts

Status
Ongoing
Initiation date
2024-07-23
Report date
2024-09-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lejre, Denmark

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3186-2024