Smiths Medical Medfusion Syringe Infusion Pump Recall for Clamp Mechanism Defect
Smiths Medical ASD Inc. 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 3/5 (High).
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 involves a medical device used for precise fluid administration. The hazard is a risk of harm due to device malfunction (false alarms) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Smiths Medical ASD Inc. is recalling 9,787 units of the Medfusion Syringe Infusion Pump, Model No. 4000, Software Version V1.1. The recall covers units distributed worldwide, including the United States, Canada, Great Britain, Panama, Germany, India, the Philippines, and Oman.
The recall is due to a potential defect in the syringe barrel clamp mechanism. If the mechanism loosens, the pump may be unable to accurately detect the diameter of the syringe barrel. This can result in the unit initiating an "Invalid Syringe Size" alarm, which may interfere with the administration of fluids requiring precisely controlled infusion rates.
Healthcare facilities and users should stop using the affected pumps and contact Smiths Medical ASD Inc. for further instructions on the recall.
The recalled product
- Product
- Medfusion, Syringe Infusion Pump, Software Version V1.1, 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 blood…
- 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. 4000
- Reference No. 4000-0101-51
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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