Z-1439-2017Class II

CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15

Name: Z-1439-2017 CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15
Creator: Smiths Medical ASD, Inc.
Published: 2016-10-31
License: https://open.fda.gov/license/

Abbott Medical / initiated 2016-10-31 / Terminated / root cause: software

FDA source

Smiths Medical ASD, Inc. began a recall of CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15 on 2016-10-31. FDA classified it as Class II and gives the reason as "20 Pumps sold to the Finnish market contain a message in which one word in the message is mistranslated. When the user follows a specific set of key presses the pump will display the incorrect message. The message...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1439-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-31
Posted: 2017-03-10
Terminated: 2019-07-15
Recalling firm: Abbott Medical
Product: CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,
Product code: MEA Pump, Infusion, Pca
Reason for recall: 20 Pumps sold to the Finnish market contain a message in which one word in the message is mistranslated. When the user follows a specific set of key presses the pump will display the incorrect message. The message indicates that a Patient Controlled Analgesia (PCA) dose is unavailable because the pump is running. It should indicate that the PCA dose is not available because the pump is stopped. The function of the pump is unchanged and no patient injury can occur since no drug is being delivered.
Root cause tag: software
FDA root cause: Software design
Action: Smiths Medical sent an Urgent Medical Device Field Safety Notice dated October 26, 2016, via FedEx on October 31, 2016. The letter described the Reason for Field Corrective Action, Risk to Health, and Instructions to Customers. Advised consignees to contact the Smiths Medical Service & Repair Department for the software to be loaded and to complete the Recall Confirmation Form and return it to Smith Medical via e-mail to [email protected]. For further questions please call (651) 633-2556.
Quantity in commerce: 20
Distribution: Internationally to Finland
Product codes and lots: 1071155, 1076826, 1081258, 1081260, 1081275, 1082475, 1082511, 1082512, 1090347, 1090348, 1090349, 1091767, 1091768, 1091769, 1091770, 1091771, 1092395, 1100186, 1100188, 1100189.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1439-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1439-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-10

Product code MEA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)