CADD-Solis Medication Safety Software, Administrator CD… recallZ-0166-2015 · Smiths Medical ASD, Inc. · initiated Sep 29, 2014
Class II Terminated All recalls posted in November 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smiths Medical ASD, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Process control
What the company is doing
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 [email protected]. For questions customers can contact Smiths Medical's Customer Service Department at 1-800-258-5361.
Recall details
- Recall number
- Z-0166-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 29, 2014
- Posted by the FDA
- Nov 1, 2014
- Recalling firm
- Smiths Medical ASD, Inc.
- Quantity
- 24
- Product code
- MEA
- FDA submissions
- K072144
- Distribution
- US Nationwide Distribution in the state of AK, CA, CO, CT, GA, MI, MN, NH, NC, SC, TX, VA, WI.
Product description
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 (models, lots, serial numbers)
Lot Number 2752712
Other devices under the same FDA submission
3 devices cleared under K072144 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CADD 21-2112-0100-51Icu Medical, Inc. · Pump, infusion, pca2 recalls59 reports
- CADD 21-2160-51Icu Medical, Inc. · Pump, infusion, pca16 reports
- CADD 21-2145-01Icu Medical, Inc. · Pump, infusion, pca1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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