FDAClass IISeptember 25, 2024

VariSoft Infusion Set recall

VariSoft Infusion Set, Single Use.

Why was VariSoft Infusion Set recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 05705244018747. Product Code: 1726035. Lot Number: 6005241

Product
VariSoft Infusion Set, Single Use.
Recalling firm
Unomedical A/S
Distribution
US Nationwide distribution in the state of California.
Recall date
September 25, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls