Company: Smiths Medical ASD Inc.
Date of Enforcement Report: 8/2/2024
Class: I
PRODUCT
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
Recall Number:
Z-2419-2024
REASON:
CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following issues:1. Upstream Occlusion, 2. Stop and Power Keys Unresponsive, 3. Manual Mode Air Detector, 4. Single Bubble Air Detection, 5. Error Codes Not Displayed at Power Up, 6. Audible Alarm, 7. Low Sensitivity Air in Line Detection more…
RECALLING FIRM/MANUFACTURER:
Smiths Medical ASD Inc.
VOLUME OF PRODUCT IN COMMERCE:
9284 units
DISTRIBUTION:
Worldwide
