FDAMarch 8, 2016device
Diana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223 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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