Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0989-2017 — i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448

U.S. FDA — Device Enforcement · Italy · 2016-11-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0989-2017
Date of alert
2016-11-23
Country / jurisdiction
Italy
Risk level
Class II
Risk type
recall
Brand
HEALTH ROBOTICS S.R.L.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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