FDAFDA · Food and drugs·Recall number Z-0989-2017
i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448
Published January 18, 2017 · Recall initiated: November 23, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- HEALTH ROBOTICS S.R.L.
- Distributor
- Shipped throughout United States.
- Lot
- All serial numbers are affected.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Italy
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