Smiths Medical Medfusion Pump Guide Barrel Clamp Molding Defect Recall
Smiths Medical is recalling Medfusion Guide Barrel Clamps due to a molding defect that could cause spring slippage, preventing the pump from recognizing or correctly identifying loaded syringes.
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 with no reported illnesses or injuries. The molding defect presents a risk of pump malfunction that could lead to dosing errors, meeting the criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD Inc. is recalling the Medfusion Guide Barrel Clamp (Part Number G6000716) for use in Medfusion Model 4000, 3500, and 3010 infusion pumps. The affected components contain a molding defect that may allow the spring in the barrel clamp assembly to slip.
If spring slippage occurs, the pump may fail to recognize that a syringe has been loaded, or it may misidentify the size of the loaded syringe. This could result in the pump being unable to deliver medication correctly.
Approximately 1,842 guide barrel clamps have been distributed worldwide under lot numbers P0407365, P0486670, and P0561740. Healthcare facilities should verify whether their infusion pumps contain affected components by checking the lot numbers on their equipment.
The recalled product
- Product
- Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 1,842
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 (3)
- Lot Numbers: P0407365
- P0486670
- P0561740
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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