Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0107-2022 · Posted 2021-10-19

Recalling FirmSmiths Medical ASD Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2020-03-24
Date Terminated2023-12-22
Product Quantity642 units

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.

Firm Action

The firm notified its consignees by email beginning 03/24/2020. The notice explained the issue, risk to health, and requested a response. Distributors/pharmacy suppliers were directed to notify their customers. The firm is seeking return of the units for correction.

Root Cause

Component change control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111275CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARESmiths Medical Asd, Inc. · 2013-02-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑