Smiths Medical Medfusion Syringe Pump Recall for Inaccurate Dose Delivery
Smiths Medical is recalling Medfusion Syringe Pump Model 4000 units due to a risk of inaccurate drug delivery following interrupted bolus or loading doses.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly identifies the agency classification as 'Class I', which corresponds to a reasonable probability of serious adverse health consequences or death, mandating a Critical severity score per the rubric.
Plain-English summary
Smiths Medical ASD Inc. is recalling Medfusion Syringe Pump Model 4000 units equipped with software versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1. The recall involves 35,616 units that were distributed worldwide, including in the United States, Canada, and various countries in Europe, Asia, and the Middle East.
The recall is being conducted because inaccurate delivery can occur following an interrupted Bolus or Loading dose if a specific sequence of events occurs. This defect poses a risk of patients receiving incorrect medication dosages.
Healthcare facilities and consumers should contact Smiths Medical ASD Inc. for instructions on how to address this issue. The agency has classified this as a Class I recall, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Syringe Pump
- Hazard
- Affected units
- 35,616
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 (10)
- Model Numbers: 4000-0105-249
- 4000-0105-50
- 4000-0105-51
- 4000-0105-78
- 4000-0106-00
- 4000-0106-01
- and 4000-0106-231. Software Versions V1.5.0
- V1.5.1
- V1.6.0
- and V1.6.1
Distribution
Distribution scope not specified by the agency.
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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