Medfusion Infusion Pump Plunger Sensor Calibration Drift Recall
Smiths Medical is recalling Medfusion infusion pump components due to a force sensor calibration issue that may cause delayed occlusion detection, false alarms, or system failures. No injuries have been reported.
What this means for you
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 safety-critical medical device (infusion pump component) where sensor calibration drift may impair occlusion detection or trigger false alarms. No injuries reported; classified as High per the rubric for risk-of-harm products without reported harm.
Plain-English summary
Smiths Medical ASD Inc. is recalling the Medfusion Plunger Float Plate (Component Number G6000069), a component used in Medfusion infusion pumps. Approximately 674 units are affected, distributed in the United States and Canada, with production dates before April 2022.
The force sensor in the occlusion detector may drift out of calibration over time. This can result in delayed detection of line blockages, false occlusion alarms, or a System Failure Alarm when the calibration shift is significant.
The elevated risk of sensor calibration drift affects devices manufactured before April 2022, due to mechanical interference within the plunger head assembly. No injuries or illnesses have been reported. Smiths Medical is notifying customers of this issue as a precautionary measure.
The recalled product
- Product
- Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- calibration-drift
- false-occlusion-alarm
- delayed-detection
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 (14)
- Lot Numbers: P0048777
- P0067276
- P0094724
- P0102958
- P0131089
- P0266366
- P0412271
- P0725712
- P0729657
- P0744687
- P0745394
- P112621
- P122904
- P129485
Distribution
Distributed nationwide across the United States.
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