ICU Medical Recalls Diana Automated Compounding Systems for Accuracy Issues
ICU Medical is recalling 36 Diana Automated Compounding Systems because they may not meet accuracy specifications when mixing volumes under 5ml.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a functional defect (inaccurate mixing) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
ICU Medical, Inc. is recalling 36 units of the Diana Automated Compounding System, also known as Diana Onco Plus (Item No. ASN220). The device is an automated compounding system used by pharmacists to prepare solutions for patient infusion.
The recall was initiated after ICU Medical received a report that the Diana Compounding System did not meet accuracy specifications when mixing volumes under 5ml. The affected units were distributed nationwide in the United States and in various countries worldwide, including Australia, Belgium, Brazil, Canada, and others.
Healthcare facilities and users should stop using the affected devices and contact ICU Medical for further instructions. The recall covers all serial numbers of the identified product.
The recalled product
- Product
- Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 36
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
Distribution
Part of a larger recall action
This product is one of 6 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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