ICU Medical Recalls Diana Automated Compounding Systems Due to Volume Accuracy Issues
ICU Medical is recalling 47 Diana Automated Compounding Systems because they may not meet accuracy specifications when mixing volumes under 5ml.
What this means for you
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 used for patient infusion where accuracy failures could lead to incorrect dosing, representing a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling 47 units of the Diana Automated Compounding System, Final Assembly, Diana Onco Plus (Item No. CH5000, CH5000R). The Diana is an automated compounding device used by pharmacists to prepare solutions for patient infusion.
The recall was initiated after ICU Medical received a report that the device 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 contact ICU Medical for instructions on how to address the accuracy issue with the affected devices.
The recalled product
- Product
- Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No. CH5000, CH5000R 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
- 47
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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