Z-1368-2016Class II

Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No. CH5000, CH5000R The Diana is an...

Name: Z-1368-2016 Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No. CH5000, CH5000R The Diana is an...
Creator: ICU Medical, Inc.
Published: 2016-03-08
License: https://open.fda.gov/license/

Abbott Medical / initiated 2016-03-08 / Terminated

FDA source

ICU Medical, Inc. began a recall of Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No. CH5000, CH5000R The Diana is an automated compounding device for the accurate... on 2016-03-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1368-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-08
Posted: 2016-04-11
Terminated: 2016-08-17
Recalling firm: Abbott Medical
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.
Product code: NEP System/Device, Pharmacy Compounding
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.
FDA 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 [email protected]. 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: [email protected].
Quantity in commerce: 47 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.
Product codes and lots: All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1368-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1364-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-11
Z-1365-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-11
Z-1366-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-11
Z-1367-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-11
Z-1368-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-11
Z-1369-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-11

Product code NEP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)