Aug

2024

FDA Recall: Devices with Outdated Software Versions Causing Multiple Erros

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

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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FDA Recall: Devices with Outdated Software Versions Causing Multiple Erros

Allison Pate

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