Smiths Medical Medfusion Syringe Pumps Recalled for Syringe Misidentification
Smiths Medical is recalling Medfusion Syringe Pumps because they may fail to recognize or misidentify loaded medication syringes, preventing proper programming.
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 involves a risk-of-harm product where the defect could lead to medication administration errors, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Smiths Medical ASD Inc. is recalling certain Medfusion Syringe Pump models, including the Series 3100, 3500, and 4000. The recall involves 16,600 pumps distributed worldwide, including across the United States and in countries such as Australia, Canada, and the United Kingdom.
The recall is due to a defect where the pumps may not recognize or may misidentify loaded medication syringes. If the pump cannot recognize the syringe, it cannot complete the programming process. If the pump misidentifies the syringe, it may incorrectly interpret the syringe size.
Healthcare facilities and consumers should stop using the affected pumps and contact Smiths Medical ASD Inc. for further instructions on how to resolve the issue.
The recalled product
- Product
- Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other t
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Infusion Pumps
- Affected units
- 16,600
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 (13)
- Product Codes 3500G
- 3500VX
- 3500-414
- 3500-402
- 3500-0600-249
- 3500-0600-00
- 3500-0600-01
- 3500-0600-50
- 3500-0600-51
- 3500-0600-82
- 3500-306
- 3500-415
- 3500-500
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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