Z-0989-2017 Class II Terminated
FDA device recall Z-0989-2017 was initiated by HEALTH ROBOTICS S.R.L. on November 23, 2016 and is designated Class II. 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. The recall status is terminated (terminated March 15, 2017). Affected quantity: 121 systems.
Recall Details
- Product Type
- Devices
- Report Date
- January 18, 2017
- Initiation Date
- November 23, 2016
- Termination Date
- March 15, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 121 systems
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.
Distribution Pattern
Shipped throughout United States.
Code Information
All serial numbers are affected.