Medfusion Syringe Pumps Recalled for Syringe Misidentification Risk
Smiths Medical ASD Inc. is recalling Medfusion Syringe Pumps because they may fail to recognize or misidentify loaded medication syringes, potentially preventing proper pump programming.
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 the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Smiths Medical ASD Inc. is recalling certain Medfusion Syringe Pump models, specifically the Series 3100, 3500, and 4000. The recall involves 16,600 pumps that were distributed worldwide, including in the United States, Australia, Canada, and other international markets.
The recall was initiated because these pumps may not recognize or may misidentify loaded medication syringes. If a pump fails to recognize a syringe, it cannot complete the programming process. If the pump misidentifies the syringe, it may incorrectly interpret the syringe size. These issues could impact the administration of fluids requiring precisely controlled infusion rates.
Healthcare facilities and users of these devices should contact Smiths Medical ASD Inc. for further instructions on how to address the issue. The source text does not specify a particular action for consumers to take immediately, such as stopping use, but indicates a defect in the device's ability to process syringe information.
The recalled product
- Product
- Medfusion Syringe Pump 4000 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…
- 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 (7)
- Product Codes: 4000-0101-50
- 4000-0101-51
- 4000-0105-50
- 4000-0105-51
- 4000-0150-78
- 4000-0106-00
- 4000-0106-01
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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