ICU Medical, Inc. recalls Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No. CH5000, CH5000R The Diana is an automated…

Recall date

March 8, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1368-2016

FDA classification

Class II

Brand / firm

ICU Medical, Inc.

Sold / 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.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.