FDA-Device2017-01-18Class II
i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448
HEALTH ROBOTICS S.R.L.
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.
Sold states
Shipped throughout United States.
Affected count
121 systems
Manufactured in
Via Sebastian Altmann 9 A, 39100, Bolzano, Italy
Products
i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0989-2017Don't want to check this manually?
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