# FDA recall Z-0107-2022

> **Smiths Medical ASD Inc.** · Class I · device recall initiated 2020-03-24.

## Product

CADD-Solis VIP ambulatory infusion pump, Model Numbers:  a. 21-2120-0105-02L  b. 21-2120-0105-03L  c. 21-2120-0105-06L  d. 21-2120-0105-07L  e. 21-2120-0105-08L  f. 21-2120-0105-12L  g. 21-2120-0105-13L  h. 21-2120-0105-14L  i. 21-2120-0105-15L  j. 21-2120-0105-17L  k. 21-2120-0105-50L  l. 21-2127-0105-02L  m. 21-2127-0105-06L  n. 21-2127-0105-50L

## Reason for recall

Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. If an AILD does not sufficiently discern fluid from air in line, an air in line event may not be recognized by the pump and may not alarm to notify the clinician.

## Distribution

Distribution to European countries: BE, BH, CH, DE, DK, ES, FI, FR, GB, IT, HL, NO, PT, SE

## Key facts

- **Recall number:** Z-0107-2022
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-03-24
- **Report date:** 2021-10-27
- **Termination date:** 2023-12-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0107-2022

## Citation

> AI Analytics. FDA recall Z-0107-2022. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-0107-2022. Source: US FDA. Licensed CC0.

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