CanadaWhat's being recalled
Companies: Rocket Medical Also Trading As Nusurgix, Sedling Road, Washington, Tyne And Wear, United Kingdom, NE38 9BZ.
How to identify it
Affected products: Filter Set For Cook K-Mar 5200 Pumps; Lot or serial number: All lots.; Model or catalogue number: R57687
The hazard
For the device in question and, therefore, what was imported as a Class I device, has now been determined to be a Class II device. As there is no Class II license for this device with Health Canada (HC), the import and sale are now in violation of the Medical Devices Regulations (MDR).
What to do
Affected customers will be notified, with instructions to follow on withdrawal of this device.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)