CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 2
FDA device recall Z-0107-2022 · posted 2021-10-19 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 642 units
- Distribution
- Distribution to European countries: BE, BH, CH, DE, DK, ES, FI, FR, GB, IT, HL, NO, PT, SE
- Date initiated
- 2020-03-24
- Date posted
- 2021-10-19
- Date terminated
- 2023-12-22
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE (K111275) | Smiths Medical Asd, Inc. | 2013-02-01 |