Recall Z-0107-2022 ยท FRN Pump, Infusion
Smiths Medical ASD Inc.
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
| Date | Oct 19, 2021 (initiated Mar 24, 2020) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Component change control |
| 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. |
| Quantity | 642 units |
| Distribution | Distribution to European countries: BE, BH, CH, DE, DK, ES, FI, FR, GB, IT, HL, NO, PT, SE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111275 | CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE Smiths Medical Asd, Inc., Feb 1, 2013 |