Smiths Medical ASD, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1439-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 31, 2016

Date Posted: March 22, 2017

Recall Number: Z-1439-2017

Event ID: 76189

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.

Status: Terminated

Product Quantity: 20

Code Information:

1071155, 1076826, 1081258, 1081260, 1081275, 1082475, 1082511, 1082512, 1090347, 1090348, 1090349, 1091767, 1091768, 1091769, 1091770, 1091771, 1092395, 1100186, 1100188, 1100189.

Distribution Pattern:

Internationally to Finland

Voluntary or Mandated:

Voluntary: Firm initiated