The Recall Desk
HighFDA (Devices)·Z-1682-2025·Announced 2025-05-14

[pending] CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH

Pending LLM rewrite. Source: FDA_DEVICE Z-1682-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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

The recalled product

Product
CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-01; 2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD ENABLED, 1/EA, Model Number: 21-2120-0105-01; 3) PUMP KI
Manufacturer
Smiths Medical ASD, Inc.
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • All serial numbers. 1 ) 21-2127-0105-01
  • UDI-DI: 15019517150292
  • 2 ) 21-2120-0105-01
  • UDI-DI: 15019517150001
  • 3 ) 21-2120-0103-01
  • UDI-DI: 15019517084368
  • 4 ) 21-2120-0102-51
  • UDI-DI: 10610586042829
  • 5 ) 21-2120-0104-01
  • UDI-DI: 15019517126587
  • 6 ) 21-2120-0103-51
  • UDI-DI: 15019517096378
  • 7 ) 21-2127-0104-01
  • UDI-DI: 15019517126600
  • 8 ) 21-2120-0105-00
  • UDI-DI: 15019517149999
  • 9 ) 21-2120-0103-78
  • UDI-DI: 15019517096392
  • 10 ) 21-2120-0102-78
  • UDI-DI: 10610586042836

Distribution

Distributed nationwide across the United States.

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