ICU Medical Recalls Diana Automated Compounding System Due to Accuracy Issues
ICU Medical is recalling 49 units of the Diana Automated Compounding System because it 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 with a reported accuracy defect that could impact patient safety, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling 49 units of the Diana Automated Compounding System (Diana V1.3, Item No. CH5300, CH5300R). The device is an automated compounding system used by pharmacists to prepare solutions for patient infusion. The recall covers all serial numbers.
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, China, Germany, and others.
Healthcare facilities and users of the Diana Automated Compounding System should stop using the affected units and contact ICU Medical for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Diana Automated Compounding System, Diana V1.3, Item No. CH5300, CH5300R 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
- 49
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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