CLASS II Device recall · Reported 18 Jan 2017 · FDA Enforcement Report
i.v. Station and i.v. Station ONCO Automated Drug recalled
Health Robotics S.r.l is recalling i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy. The recall was initiated on 23 Nov 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0989-2017
- FDA event ID
- 76102
- Recalling firm
- Health Robotics S.r.l, Bolzano
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Nov 2016
- FDA classified
- 10 Jan 2017
- Reported
- 18 Jan 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 23 Nov 2016 | Recall initiated by company | |
| 10 Jan 2017 | Classified by FDA | +48 days |
| 18 Jan 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448
Where it was distributed
Shipped throughout United States.
Questions about this recall
Why was it 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.
Which lots are affected?
All serial numbers are affected.
Where was it sold?
Shipped throughout United States.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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