Smiths Medical Recalls Medfusion 4000 Syringe Infusion Pumps for Electrical Shorting
Smiths Medical is recalling Medfusion 4000 Syringe Infusion Pumps because conductive fluids entering the AC power receptacle can cause electrical shorting, sparking, or flames.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device with a defect that can cause sparking and flames, posing a significant risk of injury or property damage, which aligns with the 'Severe' criteria for significant injury/property-damage reports or structural defects.
Plain-English summary
Smiths Medical is conducting a recall of all Medfusion 4000 Syringe Infusion Pumps. The recall involves 9,560 units, with 8,601 distributed in the United States and 959 outside the U.S. These devices are designed for use by healthcare professionals to administer IV solutions, drug solutions, blood products, and enteral feedings.
The recall is due to an identified issue with electrical shorting at the AC power receptacle. This shorting can occur when saline solution or other conductive fluids, such as potassium chloride, enter the receptacle. When this happens, sparking and/or flames accompanied by smoke may appear at the AC power receptacle.
The affected units were distributed worldwide, including nationwide in the United States and in Canada, Saudi Arabia, and Australia. All Medfusion 4000 Syringe Pumps in the field are affected by this Field Safety Corrective Action.
The recalled product
- Product
- Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. These pumps are indicated for use by healthcare professionals in the delivery of IV…
- Manufacturer
- Smiths Medical ASD, Inc.
- Category
- Medical Device — Infusion Pumps
Distribution
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