Recall Z-1368-2016 ยท NEP System/Device, Pharmacy Compounding
ICU Medical, Inc.
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.
| Date | Mar 8, 2016 |
| Status | Terminated |
| Reason | 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 | 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 O |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.