Recall Z-0989-2017— HEALTH ROBOTICS S.R.L.
Class II · Terminated
Class II FDA medical device recall by HEALTH ROBOTICS S.R.L., initiated 2016-11-23, terminated 2017-03-15. FDA's recall record names no specific 510(k) clearance for this event. Product: i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448. Reason: 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..
- Recalling firm
- HEALTH ROBOTICS S.R.L.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-23
- Terminated
- 2017-03-15
- Firm location
- Bolzano, Italy
Product description
i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.