The Recall Desk
HighFDA (Devices)·Z-0078-2024·Announced 2023-10-18

Syringe Pump Force Sensor Drift May Cause Detection Delays or False Alarms

Smiths Medical Medfusion syringe pumps may have force sensors that drift out of calibration, causing delays in detecting line occlusions or triggering false alarms. Devices produced before April 2022 are at higher risk.

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: FDA Class II recall addressing a critical safety function (occlusion detection) with potential for patient harm. The notice contains no reports of hospitalization or injuries, and the precautionary language indicates a theoretical hazard without reported cases.

Plain-English summary

Smiths Medical ASD Inc. is recalling the Medfusion Syringe Pump Model 3500-0600-XX with all sub-models (0600-00, 0600-01, 0600-50, 0600-51, 0600-82, 0600-249) and software versions v3 through v6. Approximately 20,383 pumps have been distributed in the US and Canada. The recall addresses a potential issue with the force sensor in the occlusion detection system.

The force sensor may drift out of calibration over time. Devices produced before April 2022 are at increased risk due to mechanical interference between parts of the plunger head assembly. When the sensor calibration shifts significantly, the pump displays a System Failure Alarm. When the shift is smaller, it can either increase the time to detect a true occlusion or cause false occlusion alarms without an actual blockage.

The FDA is notifying all customers of this potential issue out of an abundance of caution.

The recalled product

Product
Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 0600-249; software versions: v3, v4, v5, and v6
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Infusion Pump
Hazard
  • sensor-drift
  • false-alarm
  • delayed-detection
  • system-failure

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 (13)

  • a) 0600-00
  • UDI/DI 10610586041259
  • b) 0600-01
  • UDI/DI 10610586041242
  • c) 0600-50
  • UDI/DI 10610586043284
  • d) 0600-51
  • UDI/DI 10610586043291
  • e) 0600-82
  • UDI/DI 10610586043017
  • f) 0600-249
  • UDI/DI 10610586041297
  • All serial numbers

Distribution

Distributed nationwide across the United States.

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