CLASS II Device recall · Reported 20 Apr 2016 · FDA Enforcement Report

Diana Automated Compounding System, Diana Onco Plus recalled

ICU Medical is recalling Diana Automated Compounding System, Diana Onco Plus 1.2, distributed nationwide in the US. The recall was initiated on 8 Mar 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Serial Numbers

Quantity recalled57 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1365-2016
FDA event ID: 73528
Recalling firm: ICU Medical, San Clemente, CA
Classification: Class II
Status: Terminated
Recall initiated: 8 Mar 2016
FDA classified: 11 Apr 2016
Reported: 20 Apr 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

8 Mar 2016	Recall initiated by company
11 Apr 2016	Classified by FDA	+34 days
20 Apr 2016	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Alabama Arizona California Colorado Connecticut District of Columbia Delaware Georgia Illinois Maryland Michigan Minnesota Missouri North Carolina New Hampshire New Jersey New York Ohio Oklahoma Pennsylvania

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

All Serial Numbers

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 73528

This product is part of a recall event; the main page for the event is Diana Automated Compounding System, Diana Onco Plus recalled.

Reported	Class	Recall	Company	Reason	Where
20 Apr 2016	CLASS II	Diana Automated Compounding System, Diana Onco Plus recalled	ICU Medical	Other	Nationwide
20 Apr 2016	CLASS II	Diana Automated Compounding System, Final Assembly, Diana Onco Plus recalled	ICU Medical	Other	Nationwide
20 Apr 2016	CLASS II	Diana Automated Compounding System, Diana Onco Plus recalled	ICU Medical	Other	Nationwide
20 Apr 2016	CLASS II	Diana Automated Compounding System, Diana Onco 3xx recalled	ICU Medical	Other	Nationwide
20 Apr 2016	CLASS II	Diana Automated Compounding System, Diana V1.3 recalled by ICU Medical	ICU Medical	Other	Nationwide

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