Smiths Medical ASD, Inc.: Device Recall

Recall Details

Recall Number

Z-1681-2025

Classification

Class I

Product Type

Device

Recalling Firm

Smiths Medical ASD, Inc.

Status

Ongoing

Date Initiated

04/10/2025

Location

Minneapolis, MN, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

313,676 total units

Reason for Recall

There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

Product Description

CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0402-51; 3) PUMP KIT, CADD-SOLIS, YELLOW, MODEL 2110 1/EA, Model Number: 21-2112-0100-51; 4) PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH 1/EA, Model Number: 21-2112-0300-01; 5) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NA ENGLISH 1/EA, Model Number: 21-2111-0300-01; 6) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, CE ENGLISH 1/EA, Model Number: 21-2111-0401-51; 7) PUMP KIT, CADD-SOLIS, MODEL 2110, CE ENGLISH 1/EA, Model Number: 21-2111-0100-51; 8) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0401-51; 9) PUMP KIT, CADD-SOLIS, MDL 2100, CE ENGLISH 1/EA, Model Number: 21-2101-51; 10) PUMP KIT, CADD-SOLIS, MDL 2110, V4.0, CE ENGLISH 1/EA, Model Number: 21-2111-0400-51; 11) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, OUS ENGLISH 1/EA, Model Number: 21-2111-0300-50; 12) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2100 1/EA, Model Number: 21-2101-00; 13) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110 TRIAL/LOANER, NA ENGLISH 1/EA, Model Number: 21-2111-0300-00; 14) PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-78; 15) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2110 1/EA, Model Number: 21-2111-0100-00; 16) PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110,TRIAL/LOANER, NA ENGLISH 1/EA, Model Number: 21-2112-0300-00; 17) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, TRIAL/LOANER YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0402-78; 18) PUMP, DEMO, CADD-SOLIS, MODEL 2100, NOT FOR HUMAN USE 1/EA, Model Number: 21-2101-249; 19) PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.1, CE ENGLISH 1/EA, Model Number: 21-2111-0401-78; 20) PUMP KIT, CADD-SOLIS, YELLOW, MDL 2100 1/EA, Model Number: 21-2102-51; 21) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, NFHU, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0401-249; 22) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, NA ENGLISH 1/EA, Model Number: 21-2111-0300-231; 23) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, TRIAL/LOANER YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0401-78; 24) PUMP KIT, CADD-SOLIS, MDL 2110, V4.0, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0400-51; 25) PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, OUS ENGLISH 1/EA, Model Number: 21-2112-0300-50; 26) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110 TRIAL/LOANER, NA ENGLISH 1/EA, Model Number: 21-2111-0300-00; 27) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2110 1/EA, Model Number: 21-2111-0100-00; 28) PUMP KIT, CADD-SOLIS, MODEL 2110, CE ENGLISH 1/EA, Model Number: 21-2111-0100-51; 29) PUMP, CADD-SOLIS, MODEL 2110, CE ENGLISH OUS 1/EA, Model Number: 21-2111-0100-50; 30) PUMP KIT, CADD-SOLIS, MDL 2100, CE ENGLISH 1/EA, Model Number: 21-2101-51; 31) PUMP KIT, CADD-SOLIS HPCA, YELLOW KEYPAD, MODEL 2110, CE ENGLISH, OUS 1/EA, Model Number: 21-2112-0100-50; 32) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2100 1/EA, Model Number: 21-2101-00; 33) PUMP KIT, CADD-SOLIS, MDL 2110, v4.0, YELLOW, ENGLISH 1/EA, Model Number: 21-2112-0400-01.

Distribution Pattern

Worldwide - US Nationwide distribution.

Other Recalls by Smiths Medical ASD, Inc.

• Class I: Dangerous 04/10/2025
  Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
• Class I: Dangerous 04/10/2025
  Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
• Class I: Dangerous 04/10/2025
  There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
• Class I: Dangerous 04/10/2025
  Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
• Class II: Risk 02/14/2025
  Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.

View all recalls by Smiths Medical ASD, Inc. →