FDA Medical Device Recalls (openFDA)
ICU Medical, Inc.: Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220 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.
- Recall number
- Z-1364-2016
- Recalling firm
- ICU Medical, Inc.
- Product
- Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220 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.
- Status
- Terminated
- Initiated
- 2016-03-08
- Posted
- not on file
- Terminated
- 2016-08-17
- 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.
- Root cause
- Use error
- Action
- ICU Medical, Inc. sent customer notification letter dated March 8, 2016, to customers to inform them that 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. The letter informs the customers that ICU Medical will provide an updated Operator's Manual to provide clarity on the difference between Operating Range and Accuracy Range as soon as they are available. Customers are informed that the updated specifications are provided with the customer communication and to be used until the Operators Manual is provided. Customers are instructed to return the completed Medical Device Safety Communication Response form to ICU Medical via Fax (801) 264-1755 or by email at recall@icumed.com. Customers with any questions or require assistance relating to the customer notification letter are instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: (866)8299025 and select option 8, or email the following address: productreturns@icumed.com.
- Quantity
- 36 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.
- Lot, serial or model codes
- All Serial Numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NEP
- Firm FEI
- 2025816
- Firm city
- San Clemente
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28