Smiths Medical Medfusion Syringe Pumps Recalled for Seal Migration Risk
Smiths Medical is recalling six Medfusion Model 3500 syringe pumps in New Hampshire because a seal defect could cause the plunger rod seal to migrate during specific infusion conditions.
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 involves a medical device used in critical care where a defect could compromise precise infusion rates. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD, Inc. is recalling six units of the Medfusion Model 3500 Syringe Pump, specifically models 3500-415 and 3500-500. These devices are intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates. The affected units were distributed in the state of New Hampshire.
The recall was initiated due to an issue with the plunger rod seal. The seal has the potential to migrate inside the pump case top during slow rate or high back pressure infusions. This defect could affect the precise control of fluid administration.
The affected units are identified by the following serial numbers: M76369, M76370, M76373, M76374, M76375, and M76377. Healthcare facilities and users should check their inventory for these specific serial numbers and contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates.
- Manufacturer
- Smiths Medical ASD, Inc.
- Category
- Medical Device — Syringe Pump
- Affected units
- 6
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 (6)
- Lot/Serial Numbers: M76369
- M76370
- M76373
- M76374
- M76375
- and M76377.
Distribution
Distributed in 1 state:
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