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Recall Observatory FDA recall evidence

Device 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.

Z-1366-2016

March 08, 2016

Class II

Product summary

Firm
ICU Medical, Inc.
Event
Event 73528
Status
Terminated
Classification
Class II
Quantity
3 units
Official record key
device-enforcement:Z-1366-2016

Official wording

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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.