Filter Set For Cook K-Mar 5200 Pumps
Last updated
Summary
Product
Filter Set For Cook K-Mar 5200 Pumps
Issue
Medical devices - Unauthorised device
What to do
Affected customers will be notified, with instructions to follow on withdrawal of this device.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Filter Set For Cook K-Mar 5200 Pumps | All lots. | R57687 |
Issue
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).
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Obstetrics and gynaecology
Companies
| Rocket Medical Also Trading As Nusurgix |
| Sedling Road, Washington, Tyne And Wear, United Kingdom, NE38 9BZ |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-78234
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