Public recall detail

Aquilex Fluid Control System

2023-08-15

medium
Recall Safety notice
Quick summary

Quick summary: Aquilex Fluid Control System. Date: 2023-08-15.

Recommended action

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

Recall details

Quick summary: Aquilex Fluid Control System. Date: 2023-08-15.

Official details

Affected product details

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

BrandW.O.M. World Of Medicine GmbH
ProductAquilex Fluid Control System
IssueMedical devices - Performance
Recall classType II
IdentificationRA-74123

Affected products

ProductAquilex Fluid Control System
LotMore than 10 numbers, contact manufacturer.
ModelAQL-100PBS AQL-100P
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAquilex Fluid Control System

Issue

WOM has received complaints from customers in the United States that the display of inflow volume on the Aquilex Fluid Control System can reach its limit of 30,000 ml during long procedures. In these cases, the display does not indicate the actual inflow volume. In cases where an unusually high amount of fluid is used for distension of the patient's uterus, the calculation of the inflow and outflow volumes reaches its limit and the pump control unit display will freeze at the maximum value. There is a risk of distension fluid reaching the circulatory system of the patient's soft tissue. Recall start date: July 17, 2023

What you should do

  • Contact the manufacture if you require additional information.
Additional official information
AudienceHealthcare Industry
CategoryHealth products - Medical devices - General hospital and personal use
CompaniesW.O.M. World Of Medicine Gmbh Salzufer 8, Berlin, Berlin, Germany, 10587
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74123
Background{}
CompaniesW.O.M. World Of Medicine Gmbh Salzufer 8, Berlin, Berlin, Germany, 10587
AudiencesHealthcare Industry
Source updated2023-08-15

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

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