Smiths Medical Recalls CADD-Solis Pumps Due to Locking Assembly Binding
Smiths Medical is recalling CADD-Solis Ambulatory Infusion Pumps because the locking assembly may bind, preventing the cassette or keypad from locking securely.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical defect in a medical device that could compromise the secure delivery of medication, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD, Inc. is recalling specific models of the CADD-Solis Ambulatory Infusion Pump, including Models 2111, 2112, and 2120. The recall involves 4,426 units distributed in the United States and internationally.
The recall is due to an intermittent issue where the locking assembly may bind after the medication cassette or administration set is latched to the pump. This binding can prevent the key from fully rotating the Cassette/Keypad Lock to the locked position, potentially compromising the security of the device.
Affected units were distributed nationwide in the US and in various countries including Canada, Australia, and several European nations. Users should check their pump serial numbers against the provided list and contact Smiths Medical for instructions on how to address the defect.
The recalled product
- Product
- CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
- Manufacturer
- Smiths Medical ASD, Inc.
- Category
- Medical Device — Infusion Pump
Distribution
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