Smiths Medical ASD Inc. is recalling approximately 12,850 Medfusion Model 4000, 3500, and 3010 syringe pumps, as well as standalone barrel clamp guides, due to a molding defect. The defect can cause a spring within the barrel clamp assembly to slip, which may prevent the pump from recognizing a loaded syringe or cause it to misidentify the syringe's size. Affected units were manufactured or serviced between July 2016 and April 2021 and were distributed worldwide. Consumers should contact their healthcare provider or the manufacturer to discuss safety protocols and necessary repairs.
The molding defect can lead to incorrect syringe identification or the failure of the device to detect a syringe entirely. This may result in delivery of the wrong dose of medication or a complete interruption of treatment, which could cause serious injury or death depending on the patient's condition and the medication being administered.
healthcare provider or manufacturer consultation
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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