FDAClass IIJanuary 18, 2017

i.v. Station and i.v. Station ONCO Automated Drug recall: Labeling Error

i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448

Why was i.v. Station and i.v. Station ONCO Automated Drug recalled?

The firm has initiated a product correction due to a bag carousel motor error causing misalignment and resulting in a mislabeling of final IV bag preparations.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

All serial numbers are affected.

Product
i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448
Recalling firm
HEALTH ROBOTICS S.R.L.
Quantity
121 systems
Distribution
Shipped throughout United States.
Recall date
January 18, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls