Health Robotics Recalls i.v. Station Systems Due to Bag Mislabeling
Health Robotics S.R.L. is recalling 121 i.v. Station and i.v. Station ONCO systems because a motor error caused misalignment and mislabeling of IV bags.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a mechanical error leads to mislabeling of IV preparations, creating a risk of harm through medication error, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Health Robotics S.R.L. has initiated a product correction for 121 i.v. Station and i.v. Station ONCO Automated Drug Compounding Systems. These devices are used in pharmacy compounding to prepare intravenous (IV) bags. The recall covers all serial numbers of the affected systems.
The recall was initiated due to a bag carousel motor error that caused misalignment, resulting in the mislabeling of final IV bag preparations. The affected systems were shipped throughout the United States.
Healthcare facilities and pharmacies should contact Health Robotics S.R.L. for further instructions on how to proceed with the product correction. Consumers should not use the affected devices until further notice.
The recalled product
- Product
- i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448
- Manufacturer
- HEALTH ROBOTICS S.R.L.
- Affected units
- 121
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers are affected.
Distribution
Distribution scope not specified by the agency.
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