Z-0166-2015 Class II Terminated
FDA device recall Z-0166-2015 was initiated by Smiths Medical ASD, Inc. on Sep 29, 2014 and is designated Class II. 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… The recall status is terminated (terminated Feb 25, 2015). Affected quantity: 24.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 12, 2014
- Initiation Date
- Sep 29, 2014
- Termination Date
- Feb 25, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24
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).
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.
Distribution Pattern
US Nationwide Distribution in the state of AK, CA, CO, CT, GA, MI, MN, NH, NC, SC, TX, VA, WI.
Code Information
Lot Number 2752712
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0166-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026