Recall Z-1366-2016— ICU Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by ICU Medical, Inc., initiated 2016-03-08, terminated 2016-08-17. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- ICU Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-03-08
- Terminated
- 2016-08-17
- Firm location
- San Clemente, CA, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.