Health product recall

Aquilex Fluid Control System (2019-08-14)

Starting date:
August 14, 2019
Posting date:
August 30, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-70851

Last updated: 2019-09-05

Affected Products

Aquilex Fluid Control System

Reason

W.O.M. has received complaints regarding incorrect fluid deficit measurements. If the displayed fluid deficit is lower than the actual deficit the patient could be overexposed to distention media. Exceeding the deficit limit can lead to a serious risks such as gynaecological tur syndrome (when using electrolyte-free solutions as irrigation medium) or pulmonary/cerebral edemas (when using electrolyte-containing solutions). This potential incorrect display of fluid deficit has been attributed to loose bag shields on the cart scale.

Affected products

Aquilex Fluid Control System

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

AQL-100CBS

Companies
Manufacturer
W.O.M. WORLD OF MEDICINE GmbH
SALZUFER 8
BERLIN
10587
GERMANY