Health product recall

Aquilex Fluid Control System

Last updated

Summary

Product
Aquilex Fluid Control System
Issue
Medical devices - Performance issue
What to do

Contact the manufacture if you require additional information.

Audience
Healthcare
Industry

Affected products

Affected products Lot or serial number Model or catalogue number
Aquilex Fluid Control System More than 10 numbers, contact manufacturer. AQL-100PBS AQL-100P

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
W.O.M. World Of Medicine Gmbh
Salzufer 8, Berlin, Berlin, Germany, 10587
Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-74123