Smiths Medical Medfusion Syringe Pumps May Fail to Recognize Syringes
Smiths Medical is recalling certain Medfusion Models 4000, 3500, and 3010 syringe pumps due to a barrel clamp guide defect. The defect may prevent the pump from recognizing or correctly identifying a syringe, potentially affecting medication delivery.
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: This is an FDA Class II recall of a high-risk medical device with a potential manufacturing defect that could affect medication delivery. No illnesses or injuries have been reported, making this a scenario of potential harm without yet-reported injury.
Plain-English summary
Smiths Medical ASD Inc. is recalling certain Medfusion Models 4000, 3500, and 3010 syringe pumps manufactured or serviced between July 2016 and April 2021. The pumps contain a potentially defective Barrel Clamp Guide component that may not have been manufactured correctly.
The defect may cause the spring within the barrel clamp assembly to slip. If this occurs, the pump may fail to recognize that a syringe is loaded into the device, or it may incorrectly identify the type or size of the syringe. Either failure could prevent the pump from functioning correctly and dispensing medication as intended.
Approximately 3,821 affected pumps have been distributed worldwide to healthcare facilities. Affected users should immediately verify whether they have any of the affected units using the detailed serial number lists available from the FDA.
Healthcare providers with affected pumps should stop using them and contact Smiths Medical ASD Inc. immediately for instructions on inspection, service, or replacement. Use of affected units should be discontinued until they have been verified as safe or replaced by the manufacturer.
The recalled product
- Product
- Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o)…
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 3,821
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 (20)
- UDI/DI NONE
- Serial Numbers: M02939
- M03874
- M09235
- M09277
- M09440
- M09611
- M09616
- M10171
- M10178
- M10184
- M10211
- M10277
- M10385
- M10621
- M11229
- M12020
- M12026
- M12252
- M12253
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 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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