ICU Medical, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1364-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 8, 2016

Date Posted: April 20, 2016

Recall Number: Z-1364-2016

Event ID: 73528

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.

Status: Terminated

Product Quantity: 36 units

Code Information:

All Serial Numbers

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated