Health product recall

Aquac Uno H Reverse Osmosis System - Main Unit

Last updated

Summary

Product
Aquac Uno H Reverse Osmosis System - Main Unit
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Affected products

Affected products

Lot or serial number

Model or catalogue number

Aquac Uno H Reverse Osmosis System - Main Unit

More than 10 numbers, contact manufacturer.

F00004561

Issue

On June 14, 2022, the manufacturer Fresenius Medical Care Ag & Co. Kgaa notified Fresenius Medical Care Canada, Inc. that during regular quality inspections of Aquac Uno H devices, it was discovered that the internal ethernet cable had not been placed correctly during assembly. Instead of routing the cable outside the boundaries of the fuse board, it was routed across the board. Due to this, the cable may get in close contact to the fuse holders. This close contact can cause thermal damage to the outer jacket of the cable and apply the main voltage to the ethernet cable. If the corresponding ethernet socket outside of the device is touched, there is the risk of electrical shock to the user.

Recall start date: June 16, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies

Fresenius Medical Care Ag & Co. Kgaa

Else-Kroner-Strasse 1, Bad Homburg, Germany, 61352

Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-64315

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