ICU Medical Recalls Diana Automated Compounding Systems for Accuracy Issues
ICU Medical is recalling 57 Diana Automated Compounding Systems because they may not accurately mix volumes under 5ml.
What this means for you
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, and the hazard involves a functional accuracy defect in a medical device without reported injuries or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
ICU Medical, Inc. is recalling 57 units of the Diana Automated Compounding System, including Diana Onco Plus 1.2 models (Item No. ASN222, ASN222-GST, ASN222-R). The Diana is an automated device used by pharmacists to prepare solutions for patient infusion.
The recall was initiated after a report indicated that the 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 on the recall.
The recalled product
- Product
- Diana Automated Compounding System, Diana Onco Plus 1.2, Item No. ASN222, ASN222-GST, ASN222-R 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
- 57
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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