Z-0166-2015Class II

CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01

Name: Z-0166-2015 CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01
Creator: Smiths Medical ASD, Inc.
Published: 2014-09-29
License: https://open.fda.gov/license/

Abbott Medical / initiated 2014-09-29 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD, Inc. began a recall of CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication Safety Software-... on 2014-09-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0166-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-29
Posted: 2014-11-01
Terminated: 2015-02-25
Recalling firm: Abbott Medical
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).
Product code: MEA Pump, Infusion, Pca
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 24
Distribution: US Nationwide Distribution in the state of AK, CA, CO, CT, GA, MI, MN, NH, NC, SC, TX, VA, WI.
Product codes and lots: Lot Number 2752712

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0166-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0166-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-12	2014-10-31

Product code MEA

K072144Class IICadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software - AdministratorSmiths Medical MD, Inc. / cleared 2008-03-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)