Data Foundry

Medical device recalls 2021

CADD-Solis VIP ambulatory infusion pump — Class I medical device recall Z-0107-2022

Terminated recall by Smiths Medical ASD Inc., reported 2021-10-27. Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. If an AILD do

Recall numberZ-0107-2022
Product typeMedical device
ClassificationClass I
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSmiths Medical ASD Inc., Minneapolis, MN, United States
Recall initiated2020-03-24
Classified2021-10-19
Reported by FDA2021-10-27
Terminated2023-12-22
Quantity642 units
Serial numbers1171405, 1171406, 1171407, 1171408, 1171409, 1171410, 1171411, 1171412, 1171413, 1171414, 1171415, 1171416, 1171417, 1171418, 1171419, 1171420, 1171421, 1171422, 1171423, 1171424, 1171425, 1171426, 1171427, 1171428, 1171429 and 475 more
Model numbers21-2120-0105-02L, 21-2120-0105-03L, 21-2120-0105-06L, 21-2120-0105-07L, 21-2120-0105-08L, 21-2120-0105-12L, 21-2120-0105-13L, 21-2120-0105-14L, 21-2120-0105-15L, 21-2120-0105-17L, 21-2120-0105-50L, 21-2127-0105-02L, 21-2127-0105-06L, 21-2127-0105-50L

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0107-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.