Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 22, 2017
CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,
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 …
Smiths Medical Asd, Inc. recalled CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15, - a moderate-severity action.
CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15, was recalled by Smiths Medical Asd, Inc. in March 22, 2017. Reason: 20 Pumps sold to the Finnish market contain a message in which one word in the message is mistranslated. When…. Check the official notice for the remedy. Verify recall #Z-1439-2017 with the FDA Devices before acting.
The recall
Smiths Medical Asd, Inc. issued this moderate-severity FDA Devices recall-20 Pumps sold to the Finnish market contain a message in which one word in the message is mistranslated. When….
- Moderate
- severity level
- 20 units
- affected scope
- Class II
- classification
- March 22, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1439-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1439-2017) was formally reported on March 22, 2017, with the manufacturer initiating the action on October 31, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Smiths Medical Asd, Inc. is listed as the recalling firm, operating out of Saint Paul, MN. Federal records list the affected scope as 20.
The documented reason for this recall is: 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 indic… Distribution data in the federal record shows the product reached: Internationally to Finland. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
20
Related Recalls
6
3 from same agency
Product description
CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1439-2017 |
| Date reported | March 22, 2017 |
| Date initiated | October 31, 2016 |
| Recalling firm | Smiths Medical Asd, Inc. |
| Firm location | Saint Paul, MN |
| Affected scope | 20 |
| Distribution | Internationally to Finland |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1439-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,. Recalled by Smiths Medical Asd, Inc.. Units affected: 20.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 22, 2017. Severity: Moderate. Recall number: Z-1439-2017.
Where was the recalled product distributed? ▼
Distribution: Internationally to Finland.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1439-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 22, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.