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U.S. Department of Health and Human Services

Class 2 Device Recall CADDSolis Medication Safety Software

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  Class 2 Device Recall CADDSolis Medication Safety Software see related information
Date Initiated by Firm September 29, 2014
Date Posted November 01, 2014
Recall Status1 Terminated 3 on February 25, 2015
Recall Number Z-0166-2015
Recall Event ID 69408
510(K)Number K072144  
Product Classification Pump, infusion, pca - Product Code MEA
Product CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01.

Product Usage:
The CADD-Solis Medication Safety Software- Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD-Solis VIP Ambulatory Infusion Pump, CADD-Solis Ambulatory Infusion Pump, or CADD-Prizm PCSII Ambulatory Infusion Pump (software revision H or higher). The CADD-Solis Medication Safety Software- Point of Care allows use of a computer to send therapy-based protocols developed by the CADD-Solis Medication Safety Software.- Administrator to the CADD -Solis Ambulatory Infusion Pump and CADD-Prizm PCS I I Ambulatory Infusion Pump (software revision H or higher).
Code Information Lot Number 2752712
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
1265 Grey Fox Rd
Saint Paul MN 55112-6929
For Additional Information Contact Customer Service Department
800-258-5361
Manufacturer Reason
for Recall		 Smiths Medical has identified an issue with a single batch (Lot Number 2752712) of CADD"-Solis Medication Safety Software Administrator 3.1 CDs. CADD"-Solis Medication Safety Software Administrator 3.1 CDs were sent with the CADD"-Solis Medication Safety Software Point of Care 3.1 software loaded on them.
FDA Determined
Cause 2		 Process control
Action Consignees were hand delivered by Smiths Medical Sales representatives on 9/29/2014 a Smiths Medical "Urgent Field Safety Notice" dated 25-September-14. The letter described the problem and the product being recalled. The letter also provided the Advice on Action to be Taken by the User, Transmission of this Urgent Medical Device Recall Notice and requested consignees to complete and return the Confirmation Form by fax to 1-800-237-8033 or via email to recall.response@smiths-medical.com. For questions customers can contact Smiths Medical's Customer Service Department at 1-800-258-5361.
Quantity in Commerce 24
Distribution US Nationwide Distribution in the state of AK, CA, CO, CT, GA, MI, MN, NH, NC, SC, TX, VA, WI.
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.
510(K) Database 510(K)s with Product Code = MEA and Original Applicant = SMITHS MEDICAL MD, INC.
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