Smiths Medical Medfusion Syringe Infusion Pump Recall for Clamp Loosening
Smiths Medical is recalling Medfusion Syringe Infusion Pumps because a loose clamp mechanism may cause the device to incorrectly alarm for invalid syringe sizes.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity recall involving a functional defect without reported harm.
Plain-English summary
Smiths Medical ASD Inc. is recalling Medfusion Syringe Infusion Pumps, Software Version 6 (V6). The recall involves 9,787 units distributed worldwide, including the United States, Canada, Great Britain, Panama, Germany, India, the Philippines, and Oman. The devices are identified by Model No. 3500 and Reference No. 3500-0600-51.
The recall is due to a potential defect where the syringe barrel clamp mechanism may loosen. This loosening can decrease the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit initiating an "Invalid Syringe Size" alarm. The FDA has classified this as a Class II recall.
Healthcare facilities and users should contact Smiths Medical ASD Inc. for instructions on how to address the defect. The source text does not specify a particular action for consumers to take beyond contacting the manufacturer, nor does it report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or…
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 9,787
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model No. 3500
- Reference No. 3500-0600-51
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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