HEALTH ROBOTICS S.R.L. product recalled over labeling errors

Recall date

November 23, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

HEALTH ROBOTICS S.R.L. recalls i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number…

Recall number

Z-0989-2017

FDA classification

Class II

Brand / firm

HEALTH ROBOTICS S.R.L.

Sold / distributed

Shipped throughout United States.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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