Class II — ICU Medical, Inc.
| Recalling firm | ICU MEDICAL, INC. |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Diana Automated Compounding System, Diana Onco Plus 1.2, Item No. ASN222, ASN222-GST, ASN222-R 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. |
| Quantity | 57 units |
| Distribution | Nationwide Distribution to Nationwide in AL, AZ, CA, CO, CT, DC, GA, IL, MD, MI, MN, MO, NC, NH, NJ, NY, OH, OK, PA, TN, TX, VA.. Worldwide: AU, BE, BR, CA, CH, DE, DZ, EE, EG, ES, FI, FR, HK, HR, IL, IT, JO, KR, MX, NL, PL, SA, SE, SI, TR. |
| Initiated | 2016-03-08 |
| Classified | 2016-04-11 |
| Terminated | 2016-08-17 |
| Recall number | Z-1365-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — ICU Medical, Inc. (Z-1365-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73528/
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