Diana Automated Compounding System — Class II medical device recall Z-1368-2016
Terminated recall by ICU Medical, Inc., reported 2016-04-20, distributed nationwide. ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Dia
| Recall number | Z-1368-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., San Clemente, CA, United States |
| Recall initiated | 2016-03-08 |
| Classified | 2016-04-11 |
| Reported by FDA | 2016-04-20 |
| Terminated | 2016-08-17 |
| Distributed | Nationwide (US) |
| Quantity | 47 units |
| Model numbers | CH5000, CH5000R |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1368-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.