# Major Recall Alert: Filter Set For Cook K-Mar 5200 Pumps Recalled Due to Improper Licensing Classification
Health Canada has issued an urgent recall for the **Filter Set for Cook K-Mar 5200 Pumps**. Originally imported and sold as a Class I medical device, the product has since been determined to meet the criteria of a Class II medical device. As there is no Class II license approved for this device under Health Canada's **Medical Devices Regulations (MDR)**, its importation and distribution in Canada are now in violation of federal health policies.
This issue raises significant concerns regarding regulatory compliance and patient safety. If you or your healthcare provider uses the **Filter Set for Cook K-Mar 5200 Pumps**, read on to learn more about this recall and what actions you should take immediately.
## Why This Recall is Important
Adherence to classifications set by Health Canada is critical in ensuring medical devices are safe and effective for use. Class II medical devices require additional evidence and approvals to guarantee they meet stricter safety standards. This improper classification issue means that the **Filter Set for Cook K-Mar 5200 Pumps** has not been evaluated to meet Class II standards, presenting potential risks to users.
### Key Reasons for This Recall:
- **Improper Classification**: The product was imported as a Class I device but has been reclassified as a Class II device.
- **Lack of Licensing**: The device does not hold the necessary Class II license from Health Canada, making its sale and distribution non-compliant with MDR.
- **Patient Safety Concerns**: Without the required regulatory approvals, the safety, effectiveness, or quality of the product might not meet established standards.
## Details of the Recall
Users and distributors of the **Filter Set for Cook K-Mar 5200 Pumps** should be aware of the following details:
- **Category**: Medical Device (Class II)
- **Brand/Device**: Filter Set for Cook K-Mar 5200 Pumps
- **Reason for Recall**: Improper classification; non-compliance with Health Canada's Medical Devices Regulations.
- **Date Announced**: October 18, 2023
- **Image of Affected Product**:
- **Official Recall Source**: [Health Canada Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/filter-set-cook-k-mar-5200-pumps)
## What You Should Do
If you or your facility is currently in possession of the recalled **Filter Set for Cook K-Mar 5200 Pumps**, take the following steps immediately to ensure compliance and safety:
- **Cease Use**: Stop using the product immediately.
- **Contact Your Supplier**: Notify the distributor or supplier where the product was purchased to discuss return options or refunds.
- **Report Adverse Events**: If you suspect any harm caused by the use of this product, report it to Health Canada's MedEffect program.
- **Inform Staff**: Make sure all relevant personnel in your facility are aware of the recall and have discontinued using the affected item.
For further details or support on returning the product, reach out to the manufacturer or Health Canada directly using the links and information provided in the official recall notice [here](https://recalls-rappels.canada.ca/en/alert-recall/filter-set-cook-k-mar-5200-pumps).
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Stay informed and stay safe. For official guidance, visit the [Health Canada recall notice here](https://recalls-rappels.canada.ca/en/alert-recall/filter-set-cook-k-mar-5200-pumps). If you have further questions, consult a medical professional or Health Canada for trusted advice.