FDA Device recall Z-0166-2015
CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01
- FDA Device
- Class II
- terminated
- Published 2014-11-12
On 2014-11-12 the FDA classified a Class II recall of CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01 by Smiths Medical Asd, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0166-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-29 |
| Published | 2014-11-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Smiths Medical Asd |
| Distribution | US |
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).
Reason
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.
Identifiers
| code_info | Lot Number 2752712 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0166-2015%22
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