Z-1439-2017 Class II Terminated
FDA device recall Z-1439-2017 was initiated by Smiths Medical ASD, Inc. on Oct 31, 2016 and is designated Class II. 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… The recall status is terminated (terminated Jul 15, 2019). Affected quantity: 20.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 22, 2017
- Initiation Date
- Oct 31, 2016
- Termination Date
- Jul 15, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20
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.
Distribution Pattern
Internationally to Finland
Code Information
1071155, 1076826, 1081258, 1081260, 1081275, 1082475, 1082511, 1082512, 1090347, 1090348, 1090349, 1091767, 1091768, 1091769, 1091770, 1091771, 1092395, 1100186, 1100188, 1100189.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1439-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026