Infusion pump component force sensor may malfunction or trigger false alarms
Smiths Medical is recalling 118 units of Medfusion infusion pump plunger case components due to potential force sensor calibration drift. The sensor may malfunction, leading to delayed occlusion detection, false alarms, or system failure.
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 medical device recall involving potential for harm (device malfunction, delayed medication delivery) but with no reported illnesses or injuries. Per the rubric, recalls involving risk-of-harm products where injury has not been reported score as High (3).
Plain-English summary
Smiths Medical ASD Inc. is recalling 118 units of the Medfusion ASSEMBLY PLUNGER CASE LEFT (Component Number G6001587), a component used in infusion pumps. The force sensor in the occlusion detector within this component may drift out of calibration over time, particularly in devices manufactured before April 2022. This calibration drift is caused by mechanical interference between parts of the plunger head assembly.
If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). If the calibration shift is smaller, the threshold to detect occlusion may increase (delaying detection) or may decrease (causing false alarms). Although such shifts may occur naturally over time with any device, an increased potential has been identified in devices produced before April 2022.
The affected components were distributed worldwide, including the US and Canada. The affected lot numbers are: P0084727, P0104753, P0106429, P0132050, P0166387, P0170765, P0171220, P0181073, P0243080, P0284277. Smiths Medical is notifying all customers of this potential issue out of an abundance of caution.
The recalled product
- Product
- Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion pump
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 118
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)
- Lot Numbers: P0084727
- P0104753
- P0106429
- P0132050
- P0166387
- P0170765
- P0171220
- P0181073
- P0243080
- P0284277
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 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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