FDA Device recall Z-1369-2016
Diana Automated Compounding System, Diana V1.3, Item No. CH5300, CH5300R The Diana is an automated compounding device for the accurate, saf…
- FDA Device
- Class II
- terminated
- Published 2016-04-20
On 2016-04-20 the FDA classified a Class II recall of Diana Automated Compounding System, Diana V1.3, Item No. CH5300, CH5300R The Diana is an automated compounding device for the accurate, saf… by Icu Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1369-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-08 |
| Published | 2016-04-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Icu Medical |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | All Serial Numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1369-2016%22
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