—#144405

Product

Diana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223 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.

FDA product code: NEP — System/Device, Pharmacy Compounding
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: All Serial Numbers

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.

Root cause (FDA determination)

Use error

Action the firm took

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.

Recalling firm

Firm: ICU Medical, Inc.
Address: 951 Calle, Amanecer San Clemente, California 92673-6212

Distribution

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.

Timeline

Recall initiated: 2016-03-08
Terminated: 2016-08-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144405. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.