# Major Recall Alert: basixCOMPAK™ MAP802, basixSKY™ Inflation Syringe MAP802, Custom Procedure Kit - Stroke Kit, and PhD™ Hemostasis Valve Recalled Due to Manufacturing Defect
## Why This Recall is Important
On **July 30, 2025**, **Merit Medical** issued an urgent recall of four medical devices—**basixCOMPAK™ MAP802**, **basixSKY™ Inflation Syringe MAP802**, **Custom Procedure Kit - Stroke Kit**, and **PhD™ Hemostasis Valve**—following a significant number of complaints. The recall was triggered by a manufacturing defect in the **PhD™ Hemostasis Valve**, specifically within its bleed back seal (secondary valve). An investigation revealed that the valve lacked fluorinated silicone due to a production error, compromising the device's function.
The defect affects the secondary valve's ability to release and close properly. In some cases, the valve cap may remain depressed, leading to potential **leakage**, which could pose serious risks during medical procedures. These issues can jeopardize patient care, emphasizing the criticality of immediate action by healthcare providers and device users.
If you’re using any of these products, read on to understand what steps you need to take.
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## Details of the Recall
Merit Medical’s investigation has provided a detailed explanation of the issue. Below is a summary of key recall details that all users of these devices should be aware of:
- **Affected Products**:
- **basixCOMPAK™ MAP802**
- **basixSKY™ Inflation Syringe MAP802**
- **Custom Procedure Kit - Stroke Kit**
- **PhD™ Hemostasis Valve**
- **Recall Start Date**: July 30, 2025
- **Defect Details**: The absence of fluorinated silicone in the bleed back seal (secondary valve) causes malfunction where the valve may not release or close properly. This results in the valve cap potentially remaining depressed, leading to leakage.
- **Reason for Recall**: Manufacturing defect caused by using the incorrect silicone mix during production.
**Visual Proof**: [Click here to see the affected products](https://myrecalls.app/images/products/29599_1755201561.jpg)
Further details and official communication can be found on the **Government of Canada website**: [Merit Medical Product Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/merit-basixcompaktm-phdtm-hemostasis-valve-and-basixskytm-inflation-syringe).
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## What You Should Do
If you’re a medical professional, healthcare provider, or user of these devices, here’s how to act:
- **Immediately Stop Use**: Cease using the affected products, particularly the **PhD™ Hemostasis Valve**, to avoid any risks related to leakage or malfunction.
- **Inspect Your Inventory**: Check your stock for the recalled product numbers listed above.
- **Contact Merit Medical**: Reach out to the manufacturer for guidance on returns, replacements, or refund processes.
- **Report Adverse Events**: If the defect has caused harm or complications, report the incident to **Health Canada's MedEffect Program** or Merit Medical directly.
Taking prompt action can help prevent adverse outcomes for you or your patients. Safety is the top priority!
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## Stay Safe – Get Instant Recall Alerts
For crucial recall updates like this one, make sure you stay informed to protect yourself and others. Download our **MyRecalls App** to:
- Track product recalls across various categories.
- Receive timely notifications for **medical device recalls**, food products, electronics, and more.
- Access reliable, government-backed sources in real-time.
[**Click here to download the MyRecalls App now!**](https://myrecalls.app)
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Protecting patient safety and ensuring product integrity is vital in the medical field. If you’re affected by this recall or know someone who uses any of these devices, don’t wait to take action. Share this information with your colleagues and network—it could save lives.
For more details, visit the **official Canadian recall alert page**: [Merit Medical Recall Announcement](https://recalls-rappels.canada.ca/en/alert-recall/merit-basixcompaktm-phdtm-hemostasis-valve-and-basixskytm-inflation-syringe).
Stay proactive, stay safe!