CLASS II Device recall · Reported 12 Nov 2014 · FDA Enforcement Report
Cadd-Solis Medication Safety recalled by Smiths Medical ASD
Smiths Medical ASD is recalling Cadd-Solis Medication Safety, distributed nationwide in the US. The recall was initiated on 29 Sep 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0166-2015
- FDA event ID
- 69408
- Recalling firm
- Smiths Medical ASD, Saint Paul, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Sep 2014
- FDA classified
- 31 Oct 2014
- Reported
- 12 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Device Malfunction
- Device type
- Infusion Pumps
Timeline
| 29 Sep 2014 | Recall initiated by company | |
| 31 Oct 2014 | Classified by FDA | +32 days |
| 12 Nov 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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).
Where it was distributed
US Nationwide Distribution in the state of AK, CA, CO, CT, GA, MI, MN, NH, NC, SC, TX, VA, WI.
Nationwide AlaskaCaliforniaColoradoConnecticutGeorgiaMichiganMinnesotaNorth CarolinaNew HampshireSouth CarolinaTexasVirginiaWisconsin
Questions about this recall
Is Cadd-Solis Medication Safety recalled?
Yes. Smiths Medical ASD recalled Cadd-Solis Medication Safety on 29 Sep 2014. The recall is Class II and its status is Terminated. Recall number Z-0166-2015.
Why was it 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.
Which lots are affected?
Lot Number 2752712
Where was it sold?
US Nationwide Distribution in the state of AK, CA, CO, CT, GA, MI, MN, NH, NC, SC, TX, VA, WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Smiths Medical ASD
All 284| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Cadd Solis Hspca Pump ***Updated 5/27/26*** Scope updated recalled | Smiths Medical ASD | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Cadd-Solis Infusion Pump recalled by Smiths Medical ASD | Smiths Medical ASD | Other | Nationwide |
| Device | CLASS I | CADD Solis VIP Ambulatory Infusion Pump recalled by Smiths Medical ASD | Smiths Medical ASD | Other | Nationwide |
| Device | CLASS I | Cadd-Solis VIP Ambulatory Infusion Pump recalled by Smiths Medical ASD | Smiths Medical ASD | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Cadd-Solis Hpca Ambulatory Infusion Pump recalled by Smiths Medical ASD | Smiths Medical ASD | Lead & Heavy Metals | Nationwide |
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