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U.S. Department of Health and Human Services

Class 2 Device Recall Diana

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  Class 2 Device Recall Diana see related information
Date Initiated by Firm March 08, 2016
Create Date April 11, 2016
Recall Status1 Terminated 3 on August 17, 2016
Recall Number Z-1365-2016
Recall Event ID 73528
Product Classification System/device, pharmacy compounding - Product Code NEP
Product Diana Automated Compounding System, Diana Onco Plus 1.2, Item No. ASN222, ASN222-GST, ASN222-R
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.
Code Information All Serial Numbers
Recalling Firm/
Manufacturer		 ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
For Additional Information Contact
949-366-2183
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 57 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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