Health product recall

Aquilex Fluid Control System and Aquilex Fluid Control System Pump Assembly

Last updated

Summary

Product
Aquilex Fluid Control System and Aquilex Fluid Control System Pump Assembly
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Aquilex Fluid Control System

More than 100 numbers, contact manufacturer.

AQL-100PBS
RM-AQL-100PBS
AQL-100P
RM-AQL-100P

Aquilex Fluid Control System Pump Assembly

More than 100 numbers, contact manufacturer.

AQL-100P

Issue

The Aquilex Fluid Control System is intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. W.O.M. had received several complaints about deficit issues in the past. The manufacturer has observed that Aquilex Fluid Management Systems were used even though the system was mechanically damaged, or the deficit function was out of specification due to overdue preventive maintenance of the device. Failure investigation performed on complaint units indicates that the function test that is stipulated in the IFU is not always performed. The IFU stipulates that a function test must be performed before the system is used to detect a malfunction of the device at an early stage. The users should become more aware and perform the function tests, which detects any kind of deviation of the deficit measurement function. Therefore, W.O.M. will perform a product field action to add a 1000 g weight to the packaging of the pump and add the new labelling during biannually preventive maintenance. After preventive maintenance an information letter is enclosed with the device which explains the changes to labeling and the execution of the function test.

Recall Start Date: May 28, 2021

Recall End Date: June 21, 2024

Old recall initiated in 2021 and web-posted delayed in September 2024 (closing date: 2024-06-21)

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
Recall class
Type II
Identification number
RA-75981

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