FDAMarch 8, 2016device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml.
What to do
FDA enforcement status: Terminated
Brands named
icu medicalicu
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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