The Recall Desk
SevereFDA (Devices)·Z-1272-2022·Announced 2022-06-29

Medfusion Syringe Pump Class I Recall: Risk of Over-Infusion or Therapy Interruption

Smiths Medical is recalling multiple Medfusion Syringe Pump models due to software and hardware defects that may interrupt drug infusion or cause over-infusion. Approximately 65,093 units distributed worldwide are affected.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall of a critical drug-infusion device. Per FDA classification, Class I recalls indicate potential for serious adverse health consequences. The identified defects—including failure of protective alarms and potential for uncontrolled infusion—pose significant risk during medication administration.

Plain-English summary

Smiths Medical ASD Inc. is recalling Medfusion Syringe Pump Models 3500 and numerous variants (with software versions 6.0.0 and 6.0.1). This Class I recall addresses eight distinct defects with potential for interruption of drug therapy or over-infusion of medication.

The identified defects include: failures of the primary audible alarm; unanticipated battery depletion alerts; time base alarm errors; continued infusion after system failure; clearing of delivered volume data; false rate alarms; incorrect bolus time displays; and DNS port issues. These malfunctions may prevent critical safety alarms from alerting clinicians or may cause unintended over-infusion of medication to patients.

Approximately 65,093 units have been distributed worldwide, including throughout the United States, US Virgin Islands, and multiple international locations. Patients depending on affected pumps for critical drug infusion therapy are potentially at risk.

Discontinue use of affected Medfusion Pump models immediately. Healthcare facilities should contact Smiths Medical ASD Inc. for device replacement or repair options. The FDA recall number for this action is Z-1272-2022.

The recalled product

Product
Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-402, 3500-414, 3500-415, 3500-500, 3500BC, 3500E, 3500G, 3500SD, 3500SD-500, 3500VX, 3500VX-306, 3500VX-414, 3500VX-415, 3500VX-500, 3500ZE, S
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
65,093

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 (20)

  • Model 3500: No UDI
  • Serial Numbers: Model 3500: No UDI
  • Serial Numbers: M63658
  • M36749
  • M16998
  • M31819
  • M62715
  • M62716
  • M29795
  • M21251
  • M32302
  • M31248
  • M31839
  • M29543
  • M22299
  • M34554
  • M29749
  • M22179
  • M25875
  • M21234

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Part of a larger recall action

This product is one of 2 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.

See all 2 products in this recall →

Related recalls

Same manufacturer · Smiths Medical ASD Inc.

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Same hazard · over infusion

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