Recall Monitor
Health Products

Filter Set For Cook K-Mar 5200 Pumps

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Obstetrics and gynaecology
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
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Filter Set For Cook K-Mar 5200 PumpsAll 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).

Get told about the next health product recall.
Get health product recall alerts

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