Public recall detail

Medfusion Syringe Infusion Pumps

medium
Recall Safety notice
Quick summary

Quick summary: Medfusion Syringe Infusion Pumps.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Medfusion Syringe Infusion Pumps.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandSmiths Medical Asd, Inc.
ProductMedfusion Syringe Infusion Pumps
IssueMedical devices - Performance
Recall classType II
IdentificationRA-74196

Affected products

ProductMedfusion Syringe Infusion Pumps
LotAll lots.
Model4000-0101-50 4000-0105-51 4000-0106-01 4000-0100-50 4000-0101-51
Serial numberAll lots.
DescriptionMedfusion Syringe Infusion Pumps
ProductMedfusion Syringe Infusion Pumps
LotAll lots.
Model3500VX-500 3500-500
Serial numberAll lots.
DescriptionMedfusion Syringe Infusion Pumps

Issue

The calibration of the force sensor used to detect occlusions may shift over time. 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 not large enough to trigger a system failure alarm, there may be a slight increase in the threshold to detect an occlusion. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Recall start date: August 8, 2023

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Healthcare Industry
CategoryHealth products - Medical devices - General hospital and personal use
CompaniesSmiths Medical ASD, Inc. 6000 Nathan Lane N., Minneapolis, Minnesota, United States, 55442
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74196
Background{}
CompaniesSmiths Medical ASD, Inc. 6000 Nathan Lane N., Minneapolis, Minnesota, United States, 55442
AudiencesGeneral public Healthcare Industry
Source updated2023-08-24

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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