Smiths Medical Recalls CADD-Solis Medication Safety Software Administrator CD
Smiths Medical is recalling a specific lot of CADD-Solis Medication Safety Software Administrator CDs because they were shipped with incorrect software loaded.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a software loading error without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Smiths Medical ASD, Inc. is recalling 24 units of CADD-Solis Medication Safety Software, Administrator CD, Version 3.1 (Lot Number 2752712). The recall was initiated because the CDs were identified as having the CADD-Solis Medication Safety Software Point of Care 3.1 software loaded on them, rather than the intended Administrator software.
The affected products were distributed nationwide in the states of Alaska, California, Colorado, Connecticut, Georgia, Michigan, Minnesota, New Hampshire, North Carolina, South Carolina, Texas, Virginia, and Wisconsin. The software is used to create therapy-based protocol libraries for CADD-Solis and CADD-Prizm ambulatory infusion pumps.
Consumers and healthcare facilities should stop using the affected CDs and contact Smiths Medical for further instructions or a replacement.
The recalled product
- 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…
- Manufacturer
- Smiths Medical ASD, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 24
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number 2752712
Distribution
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